BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISC CEFTAZIDIME CAZ-30 JAPAN

    MDR report key: 13284492 · Received January 18, 2022

    Report

    Report Number
    2647876-2021-00393
    Event Type
    Malfunction
    Date Received
    January 18, 2022
    Date of Event
    December 20, 2021
    Report Date
    February 4, 2022
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    JTN
    PMA / PMN Number
    K852873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. 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¿ CEFTAZIDIME - 30G CATALOG NUMBER 231632 WHICH HAS 510K NUMBER K852873.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-12-20. INVESTIGATION SUMMARY: A COMPLAINT INVESTIGATION DUE TO DAMAGE BOX ON CEFTAZIDIME CATALOG 291085, BATCH NO.: 1116797 WAS PERFORMED ON RETENTION SAMPLES. THE INVESTIGATION REQUIRED TO PERFORM VISUAL INSPECTION, PHOTO EVALUATION AND BATCH RECORD REVIEW. NO DISCREPANCIES OBSERVED DURING THE VISUAL INSPECTION OF RETENTION SAMPLES. BATCH RECORD REVIEW DID NOT SHOWED ANY EVIDENCE OF CUSTOMER CLAIM. PHOTO RECEIVED AS WELL RETURNED GOODS RECEIVED FROM CUSTOMER WERE EVALUATED. IT WAS OBSERVED THAT PRODUCT PACKAGING WAS COMPROMISED SINCE CUSTOMER PLACED A TAPE ON THE AFFECTED AREA ON BOX. NO CORRECTIVE ACTION IS REQUIRED BASED ON INFORMATION EVALUATED AND SATISFACTORY RESULTS OBTAINED DURING THE QC TEST. COMPLIANT 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 WHILE USING BD DISC CEFTAZIDIME CAZ-30 JAPAN 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: "ACCORDING TO THE CUSTOMER'S INFORMATION, THE PACKAGE IS TORN AND RESIDUE HAS BEEN LEFT FROM A LABEL THAT WAS PEELED OFF."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD DISC CEFTAZIDIME CAZ-30 JAPAN 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: " ACCORDING TO THE CUSTOMER'S INFORMATION, THE PACKAGE IS TORN AND RESIDUE HAS BEEN LEFT FROM A LABEL THAT WAS PEELED OFF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2233708 BD DISC CEFTAZIDIME CAZ-30 JAPAN SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL JTN BECTON DICKINSON CARIBE LTD. 1116797

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown