BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE SABOURAUD DEXTROSE AGAR CG 20 EA

    MDR report key: 14350047 · Received May 10, 2022

    Report

    Report Number
    2243072-2022-00664
    Event Type
    Malfunction
    Date Received
    May 10, 2022
    Date of Event
    April 12, 2022
    Report Date
    May 23, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    JSI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2024413; MEDICAL DEVICE EXPIRATION DATE: 2022-05-23; DEVICE MANUFACTURE DATE: 2022-01-24. MEDICAL DEVICE LOT #: 1334477; MEDICAL DEVICE EXPIRATION DATE: 2022-03-29; DEVICE MANUFACTURE DATE: 2021-11-30. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. 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¿ SABOURAUD DEXTROSE AGAR SLANTS CATALOG NUMBER 221013 WHICH IS A CLASS 1, 510(K) EXEMPT DEVICE.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 06-MAY-2022. H.6. INVESTIGATION: BD RECEIVED SAMPLES AND 3 PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR CONTAMINATION WAS OBSERVED. ADDITIONALLY, THE CUSTOMER SAMPLES WERE INSPECTED AND CONTAMINATION WAS OBSERVED. NO ISSUE WAS FOUND IN RETENTION SAMPLES. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOTS, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS BEEN CONFIRMED FOR CONTAMINATION. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING PLATE SABOURAUD DEXTROSE AGAR CG 20 EA MOLD 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: "THIS IS A REPORT ABOUT CONTAMINATION OF THE MEDIA."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING PLATE SABOURAUD DEXTROSE AGAR CG 20 EA MOLD 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: "THIS IS A REPORT ABOUT CONTAMINATION OF THE MEDIA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1997862 PLATE SABOURAUD DEXTROSE AGAR CG 20 EA CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI BECTON DICKINSON SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown