Device adverse event reports (MAUDE)

PLATE BD CHROMAGAR O-157 20 EA · CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL

BECTON DICKINSON · Contamination of Device Ingredient or Reagent

MalfunctionInitial submissionMDR 12305305
Event location
I
Report to FDA
*
Manufacturer link flag
Y
Event type
Malfunction
Report number
2243072-2021-02046
Product problem flag
Y
Date received
20210810
PMA pmn number
K070691
Date of event
20210713
Reprocessed and reused flag
N
Reporter occupation code
OTHER HEALTH CARE PROFESSIONAL
Noe summarized
1
Reporter country code
JA
Date added
20210810
Mfr report type
Thirty-Day
Date changed
20250818
Summary report flag
N
Date report
20210804
MDR report key
12305305
Date manufacturer received
20210713
Report source code
Manufacturer report
Adverse event flag
N
Type of report
Initial submission
Source type
FOREIGN, OTHER, USER FACILITY
Device
  1. Device sequence number
    1202320
    Serviced by 3rd party flag
    N
    Date received
    20210810
    Brand name
    PLATE BD CHROMAGAR O-157 20 EA
    Generic name
    CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL
    Manufacturer d name
    BECTON DICKINSON
    Manufacturer d address 1
    1 BECTON DRIVE
    Manufacturer d city
    FRANKLIN LAKES
    Manufacturer d state
    NJ
    Manufacturer d zip code
    07417
    Manufacturer d country
    US
    Manufacturer d postal code
    07417
    Device operator
    0
    Expiration date of device
    20210727
    Catalog number
    251361
    Lot number
    1104959
    Device availability
    No
    Device report product code
    JSI
    Combination product flag
    N
    Harmonized identifiers (openFDA)
    Device name
    Culture Media, Selective And Differential
    Medical specialty description
    Microbiology
    Regulation number
    866.2360
    Device class
    1
Product problems
Contamination of Device Ingredient or Reagent, Contamination of Device Ingredient or Reagent
Patient
  1. Patient sequence number
    1
    Date received
    20210810
    Patient problems
    No Clinical Signs, Symptoms or Conditions, No Clinical Signs, Symptoms or Conditions
MDR text
  1. MDR text key
    267675433
    Text type code
    Additional Manufacturer Narrative
    Patient sequence number
    1
    Text

    INVESTIGATION SUMMARY: THE DEFECT WAS NOT CONFIRMED BECAUSE THERE IS NO PICTURE AND RETURNED SAMPLE. A CUSTOMER REPORT IS NOT REQUIRED, AND IT IS KNOWN DEFECT AND THE TREND HAS NOT SHOWN A REMARKABLE RISE, SO WE DECIDED THAT FURTHER INVESTIGATIONS IS NOT NECESSARY. WE WILL CONTINUE TO MONITOR THE TREND THIS ISSUE. THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US BUT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED DEVICE BD BBL¿ CHROMAGAR¿ O157 CATALOG NUMBER 214984 WHICH HAS 510K NUMBER K070691.

  2. MDR text key
    267675434
    Text type code
    Description of Event or Problem
    Patient sequence number
    1
    Text

    IT WAS REPORTED THAT WHILE USING 20 PLATE BD CHROMAGAR O-157 20 EA CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ACCORDING TO THE CUSTOMER¿S INFORMATION, DOTS LIKE MOLD WERE FOUND ON THE MEDIA."

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How to read this: Each report says someone told FDA an event happened while a product was used. A report does not show the product caused it, and counts rise and fall with how many people report. Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.