BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BACTEC¿ STANDARD ANAEROBIC/F CULTURE VIALS (PLASTIC)

    MDR report key: 15188878 · Received August 8, 2022

    Report

    Report Number
    2647876-2022-00183
    Event Type
    Malfunction
    Date Received
    August 8, 2022
    Date of Event
    July 23, 2022
    Report Date
    September 2, 2022
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    MDB
    UDI-DI
    00382904420246
    PMA / PMN Number
    K161306
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: CATALOG 442024, BATCH NO. 1153247. CUSTOMER COMPLAINED THAT THERE WAS MANIPULATION IN EXPIRY DATE. THE EXPIRATION DATE BEEN TRIED TO CHANGE FROM 2022-06-30 TO 2022-08-30 BY DISTRIBUTOR. BD WAS UNABLE TO REPRODUCE CUSTOMER EXPERIENCE WITH BACTEC¿ PRODUCT. RETENTION SAMPLES WERE VISUALLY INSPECTED WITH SATISFACTORY RESULTS. BATCH HISTORY RECORDS REVIEW DID NOT IDENTIFY ANY EVIDENCE FROM WHICH THE CUSTOMER SUBMITTED THE COMPLAINT. A COMPLAINT HISTORY REVIEW WAS CONDUCTED AND ONLY THE CURRENT COMPLAINT WAS FOUND RELATING TO THE INCIDENT LOT NUMBER AND THE ¿AS REPORTED¿ DEFECT CODE. COMPLAINT IS CONFIRMED BASED ON PHOTOS. THESE VIALS/CARTON LABELS WERE COUNTERFEITED BY CHANGING THE EXPIRATION DATE FROM JUN'22 TO AUG'22. NO CORRECTIVE ACTIONS WERE REQUIRED. THE PRODUCT WAS COUNTERFEITED OUTSIDE OF BD CAYEY. A CROSS FUNCTIONAL TEAM CONTINUALLY MONITORS ALL PRODUCT COMPLAINTS FOR TRENDS AND DETERMINES IF ANY ADDITIONAL ACTIONS ARE NECESSARY BEYOND THE CURRENT INVESTIGATIONAL PROCESS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ STANDARD ANAEROBIC/F CULTURE VIALS (PLASTIC) THE CUSTOMER OBSERVED THAT THE LABEL DID NOT HAVE THE CORRECT EXPIRATION DATE. IT APPEARS THE LABEL WAS ADULTERATED THROUGH THE DISTRIBUTION PROCESS BASED ON PHOTOS AND THE DISTRIBUTOR INVOICE WHICH HAS THE WRONG INFORMATION. THIS EVENT OCCURRED 65 TIME(S). THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER COMPLAINED THAT THERE WAS MANIPULATION IN EXPIRY DATE"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BACTEC¿ STANDARD ANAEROBIC/F CULTURE VIALS (PLASTIC) THE CUSTOMER OBSERVED THAT THE LABEL DID NOT HAVE THE CORRECT EXPIRATION DATE. IT APPEARS THE LABEL WAS ADULTERATED THROUGH THE DISTRIBUTION PROCESS BASED ON PHOTOS AND THE DISTRIBUTOR INVOICE WHICH HAS THE WRONG INFORMATION. THIS EVENT OCCURRED 65 TIME(S). THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER COMPLAINED THAT THERE WAS MANIPULATION IN EXPIRY DATE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2249248 BD BACTEC¿ STANDARD ANAEROBIC/F CULTURE VIALS (PLASTIC) SYSTEM, BLOOD CULTURING MDB BECTON DICKINSON CARIBE LTD. 442024 1153247 00382904420246

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown