BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DIFCO HEKTOEN ENTERIC AGAR

    MDR report key: 12600439 · Received October 8, 2021

    Report

    Report Number
    1119779-2021-01625
    Event Type
    Malfunction
    Date Received
    October 8, 2021
    Date of Event
    September 13, 2021
    Report Date
    October 19, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSI
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY THIS MEMO IS TO SUMMARIZE FINDINGS ON YOUR COMPLAINT RELATED TO PAIL HEKTOEN ENTERIC AGAR 2KG, CATALOG NUMBER 285310, BATCH 1005901, COMPLAINT #3582916 FOR UNSATISFACTORY PRODUCT LABELING. THE COMPLAINT INVESTIGATION INCLUDED A REVIEW OF THE BATCH HISTORY RECORD (BHR) FOR PAIL HEKTOEN ENTERIC AGAR 2KG, BATCH 1005901. ALL QC RELEASE TESTING INCLUDING DEHYDRATED MEDIUM APPEARANCE, SOLUBILITY, SOLUTION APPEARANCE, PH, AND CULTURAL RESPONSE WITH THOSE ORGANISMS SPECIFIED ON THE BD CERTIFICATE OF ANALYSIS WAS SATISFACTORY. THE LABELING PROCESS FOR MATERIAL 285310 INCLUDES LABEL RECONCILIATION WHERE THE TOTAL NUMBER OF LABELS ISSUED IS RECONCILED WITH THE TOTAL QUANTITY OF LABELS THAT WERE APPLIED TO THE PAILS, THE BATCH HISTORY RECORD, REJECTED, AND UNUSED. A TOTAL OF 121 PAILS WERE LABELED DURING THE PACKAGING EVENT FOR BATCH 1005901. ANY DISCREPANCIES MUST BE WITHIN THE ALLOWABLE LIMITS SPECIFIED IN THE LABEL RECONCILIATION PROCEDURE. THE LABEL RECONCILIATION FOR THIS BATCH INDICATES THERE WAS NO EXCESS AFTER THE MANUFACTURING EVENT. 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. ONE PHOTO WAS RECEIVED IN LIEU OF RETURNS. THE PHOTO SHOWS SEVERAL 2KG PAILS STACKED. A PAIL ON THE BOTTOM OF ONE STACK IS LABELED AS 285310, LOT 1005901, AND EXPIRY 2025-09-30. ONE UNLABLED PAIL IS SHOWN STACKED ON TOP OF THIS PAIL. THE DEFECT HAS BEEN CONFIRMED FROM THE CUSTOMER PHOTO. THE MANUFACTURING SUPERVISOR AND RELEASE CONTROL ASSOCIATES WERE NOTIFIED OF THIS COMPLAINT FOR AWARENESS. ROOT CAUSE CANNOT BE DETERMINED FROM THE INFORMATION AVAILABLE. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD DIFCO¿ HEKTOEN ENTERIC AGAR MISSING LABEL INFORMATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NO LABEL ON THE OUTER BOX".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD DIFCO¿ HEKTOEN ENTERIC AGAR MISSING LABEL INFORMATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NO LABEL ON THE OUTER BOX"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1496650 BD DIFCO HEKTOEN ENTERIC AGAR CULTURE MEDIA, SELECTIVE AND DIFFERENTIAL JSI BECTON, DICKINSON & CO. (SPARKS) 1005901

    Patients

    Seq Age Sex Outcome Treatment
    1