BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DIFCO¿ POTATO DEXTROSE AGAR

    MDR report key: 19344206 · Received May 17, 2024

    Report

    Report Number
    1119779-2024-00386
    Event Type
    Malfunction
    Date Received
    May 17, 2024
    Date of Event
    April 19, 2024
    Report Date
    September 12, 2024
    Manufacturer
    BECTON DICKINSON & CO. (SPARKS)
    Product Code
    JSG
    UDI-DI
    00382902132004
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS ON YOUR COMPLAINT RELATED TO PAIL POTATO DEXTROSE AGAR 2KG, CATALOG NUMBER 213200, BATCH UNKNOWN, COMPLAINT #(B)(4) FOR UNSATISFACTORY PRODUCT LABELING. THE COMPLAINT INVESTIGATION WAS UNABLE TO PERFORM A REVIEW OF THE BATCH HISTORY RECORD (BHR) FOR PAIL POTATO DEXTROSE AGAR 2KG, AS THE BATCH IS UNKNOWN. COMPLAINT TRENDS WERE REVIEWED FOR A PERIOD COVERING 12 MONTHS. DURING THAT TIME, THERE HAVE BEEN NO OTHER COMPLAINTS RECEIVED ON THIS PRODUCT FOR ANY DEFECTS. THREE PHOTOS WERE RECEIVED FOR INVESTIGATION. THE FIRST PHOTO SHOWS A BUCKET OF MATERIAL WITH A PARTIALLY TORN LABEL. THE SECOND PHOTO IS A CLOSER IMAGE OF THE PRODUCT DEPICTING A TORN LABEL. THE THIRD PHOTO IS ANOTHER SIDE OF THE BUCKET SHOWING A TORN LABEL WITH THE TOP OF THE PRODUCT LABEL MISSING INCLUDING PART OF THE PRODUCT NAME, BD BRANDING AND PART NUMBER AND LOT INFORMATION. THE CUSTOMER STATED THAT THE MATERIAL 213200, LABEL PEELED OFF. LABELING IS CHECKED PRIOR TO SHIPMENT OF PRODUCT AS PART OF THE QUALITY CONTROL PROCESS. ANY TORN OR PEELING LABELS WOULD NOT PASS INSPECTION. IT IS NOT KNOWN HOW THIS LABEL BECAME DAMAGED. THIS COMPLAINT IS CONFIRMED. BD WILL CONTINUE TO TREND ON LABELING COMPLAINTS AND ASSESS PRODUCT INTENDED USES AGAINST REGULATORY REQUIREMENTS.

    Additional Manufacturer Narrative · 0

    D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD DIFCO¿ POTATO DEXTROSE AGAR PRODUCT LABEL WAS PEELED OFF. DUE TO THIS, THE LOT INFORMATION WAS MISSING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD DIFCO¿ POTATO DEXTROSE AGAR PRODUCT LABEL WAS PEELED OFF. DUE TO THIS, THE LOT INFORMATION WAS MISSING. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743443 BD DIFCO¿ POTATO DEXTROSE AGAR CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON DICKINSON & CO. (SPARKS) UNKNOWN 00382902132004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown