BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18436331 · Received January 3, 2024

    Report

    Report Number
    2647876-2023-00669
    Event Type
    Malfunction
    Date Received
    January 3, 2024
    Date of Event
    December 7, 2023
    Report Date
    March 20, 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

    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.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A COMPLAINT INVESTIGATION DUE TO INCORRECT PRODUCT PACKED FOR CEFMETAZOLE CATALOG 296785 BATCH NO.: 3058521 WAS PERFORMED ON RETENTION SAMPLES. RETURNED GOODS WERE NOT RECEIVED FROM CUSTOMER. THE INVESTIGATION REQUIRED TO PERFORM VISUAL INSPECTION AND BATCH RECORD REVIEW. CATALOG 296785 DOES NOT BELONG TO BD CAYEY. IT BELONGS TO BD JAPAN. HOWEVER, INVESTIGATION WAS PERFORMED TO CEFMETAZOLE CATALOG 231666 BATCH 3058521. NO DISCREPANCIES OBSERVED. PRODUCT WAS IDENTIFIED CORRECTLY. BATCH RECORD REVIEW DID NOT SHOW ANY EVIDENCE OF CUSTOMER CLAIM. ADDITIONAL INVESTIGATION WAS REQUESTED TO BD JAPAN. BD JAPAN INVESTIGATION RESULTS RECEIVED: "THE INVESTIGATION RESULT FROM JAPAN DC AS BELOW. NO DISCREPANCIES OBSERVED DURING THE VISUAL INSPECTION FOR INVENTORY OF 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, SO THE CAUSE COULD NOT BE DETERMINED. JAPAN DC INFORM THE WORKERS OF THIS EVENT AND RETRAIN THEM TO FOLLOW THE PROCEDURES. AND THE CATALOG NUMBER AND LOT NUMBER WOULD BE CHECKED AT LABELING WORK AND RECORDED IT IN THE WORK RECORD." NO CORRECTIVE ACTION IS REQUIRED BASED ON INFORMATION EVALUATED AND SATISFACTORY RESULTS OBTAINED DURING THE INVESTIGATION. COMPLAINT IS NOT CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED.

    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 THE INCORRECT PRODUCT. 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 THE INCORRECT PRODUCT. THERE WAS NO REPORT OF PATIENT IMPACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1549551 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