BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ SENSI-DISC¿ CEFMETAZOLE - 30 ¿G

    MDR report key: 18474562 · Received January 9, 2024

    Report

    Report Number
    2647876-2023-00670
    Event Type
    Malfunction
    Date Received
    January 9, 2024
    Date of Event
    December 11, 2023
    Report Date
    May 24, 2024
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    JTN
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: A COMPLAINT INVESTIGATION DUE TO INCORRECT PRODUCT PACKED FOR CEFMETAZOLE CATALOG 296785 BATCH NO.: 3058521 WAS REQUESTED. THIS CATALOG IS MANUFACTURED IN BD CAYEY FOR BD JAPAN REGION UNDER CATALOG NUMBER 231666. CATALOG 231666 IS RELABELED BY BD JAPAN UNDER CATALOG 296785. NEVERTHELESS, INVESTIGATION WAS PERFORMED TO CEFMETAZOLE RETENTION SAMPLES, BD CAYEY CATALOG NUMBER 231666 BATCH NUMBER 3058521. THE INVESTIGATION REQUIRED TO PERFORM VISUAL INSPECTION AND BATCH RECORD REVIEW. NO DISCREPANCIES OBSERVED. PRODUCT WAS IDENTIFIED CORRECTLY. BATCH RECORD REVIEW DID NOT SHOW ANY EVIDENCE OF INCORRECT LABELING/PRODUCT. RETURNED GOODS WERE NOT RECEIVED FROM CUSTOMER. PHOTO RECEIVED FROM CUSTOMER WAS EVALUATED. IT WAS OBSERVED THAT THE CARTRIDGE BELONGS TO AMPICILLIN BATCH 2276051 AND BD JAPAN OUTSIDE CARTRIDGE LABEL REFERRED TO CEFMETAZOLE (CMZ-30). COMPLAINT INVESTIGATION WAS EXTENDED TO BD JAPAN. A CAPA REPORT WAS CREATED. THE POSSIBLE CAUSES DERIVED FROM THE FACTS ARE THEY MIXED UP 1SP (10EA PACK) BETWEEN TWO PRODUCT LOTS AND SENT THEM TO THE PROCESS FOR SPLIT PACKING. THERE WAS NO PROCESS TO CHECK THE CONTENT OF THE LABEL ON THE CARTRIDGE IN THE BLISTER PACK, THEY WERE NOT ABLE TO FIND THE ISSUE IN-PROCESS.

    Additional Manufacturer Narrative · 0

    E1. INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. G5. 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¿ SENSI-DISC¿ CEFMETAZOLE - 30 G, CATALOG NUMBER 231666, WITH 510K # K895679. 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 PRIOR TO USE WITH THE BD BBL¿ SENSI-DISC¿ CEFMETAZOLE - 30 G, THE PACKAGE CONTAINED A WRONG PRODUCT. THE LABEL INDICATED CEFMETAZOLE, BUT THE PACKAGE CONTAINED GENTAMICIN. THERE WAS NO REPORT OF PATIENT IMPACT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH THE BD BBL¿ SENSI-DISC¿ CEFMETAZOLE - 30 G, THE PACKAGE CONTAINED A WRONG PRODUCT. THE LABEL INDICATED CEFMETAZOLE, BUT THE PACKAGE CONTAINED GENTAMICIN. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461595 BD BBL¿ SENSI-DISC¿ CEFMETAZOLE - 30 ¿G SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL JTN BECTON DICKINSON CARIBE LTD. 3058521

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown