BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17929917 · Received October 13, 2023

    Report

    Report Number
    3008352382-2023-00193
    Event Type
    Malfunction
    Date Received
    October 13, 2023
    Date of Event
    September 15, 2023
    Report Date
    November 9, 2023
    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 LABEL FOR CEFMETAZOLE (CMZ-30) CATALOG 296785 BATCH NO.: 3038521 WAS PERFORMED. THE CATALOG AND BATCH NUMBER REFERENCED IN THE COMPLAINT BELONG TO BD JAPAN. THIS PRODUCT WAS REWORKED/RELABELED BY BD JAPAN. BD CAYEY BATCH NUMBER IS 3058521 FOR CMZ-30 PRODUCT. THE INVESTIGATION REQUIRED TO PERFORM VISUAL INSPECTION ON RETENTION SAMPLES, BATCH RECORD REVIEW AND PHOTO EVALUATION. IN ADDITION, INVESTIGATION WAS EXTENDED TO BD JAPAN. BASED ON BD CAYEY INVESTIGATION RESULTS, NO DISCREPANCIES OBSERVED DURING THE VISUAL INSPECTION. BATCH RECORD REVIEW DID NOT SHOW ANY EVIDENCE OF CUSTOMER CLAIM. PHOTOS RECEIVED WERE EVALUATED. CARTRIDGE LABELED AS CATALOG 230705 BELONG TO PRODUCT AM-10. ADDITIONAL PHOTOS SHOWED BD JAPAN LABELED CARTRIDGES, MAKING REFERENCE TO CATALOG NUMBER 296785 (CMZ-30). FOLLOWING ARE THE BD JAPAN DC INVESTIGATION RESULTS: NO DISCREPANCIES OBSERVED DURING THE VISUAL INSPECTION FOR INVENTORY OF CATALOG 231666 CCMZ-30 BATCH 3058521. LABELING WORK RECORD REVIEW DID NOT SHOW ANY EVIDENCE OF CUSTOMER CLAIM. FROM ABOVE REVIEW RESULT. THERE WAS NO EVIDENCE THAT THE DEFECT WAS CAUSED BY WORK DONE IN JAPAN. NO CORRECTIVE ACTION IS REQUIRED BASED ON INFORMATION EVALUATED AND SATISFACTORY RESULTS OBTAINED DURING THE QC TEST. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED.

    Additional Manufacturer Narrative · 0

    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 THE BD BBL¿ SENSI-DISC¿ CEFMETAZOLE - 30 G WAS LABELED AS THE INCORRECT PRODUCT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: THE CARTON AND THE POUCH INDICATED PRODUCT 296785, LOT #3058521, HOWEVER, THE LABEL ON THE PRODUCT SAID 296636, LOT #2276051.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD BBL¿ SENSI-DISC¿ CEFMETAZOLE - 30 G WAS LABELED AS THE INCORRECT PRODUCT. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: THE CARTON AND THE POUCH INDICATED PRODUCT 296785, LOT #3058521, HOWEVER, THE LABEL ON THE PRODUCT SAID 296636, LOT #2276051.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1970068 BD BBL¿ SENSI-DISC¿ CEFMETAZOLE - 30 ¿G SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL JTN BECTON DICKINSON CARIBE LTD. 3058521

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown