BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ SENSI-DISC¿ CEFTAZIDIME 30 ¿G

    MDR report key: 21997189 · Received May 9, 2025

    Report

    Report Number
    2647876-2025-00049
    Event Type
    Malfunction
    Date Received
    May 9, 2025
    Date of Event
    April 11, 2025
    Report Date
    June 25, 2025
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    JTN
    UDI-DI
    30382902316337
    PMA / PMN Number
    K852873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). INVESTIGATION SUMMARY: A COMPLAINT INVESTIGATION, DUE TO DIFFERENT CATALOG LABELING ON THE INTERNAL PACKAGING ON CEFTAZIDIME CATALOG 231633, BATCH 4156643, WAS PERFORMED. THE INVESTIGATION REQUIRED TO PERFORM VISUAL INSPECTION, PHOTOS EVALUATION AND BATCH RECORD REVIEW. NO DISCREPANCIES OBSERVED DURING THE VISUAL INSPECTION. RETENTION SAMPLES WERE CORRECT AND CORRECTLY IDENTIFIED (CARTRIDGE AND BOX). RETURNED GOODS WERE NOT RECEIVED FOR THE INVESTIGATION. BATCH RECORD REVIEW DID NOT SHOW ANY EVIDENCE OF CUSTOMER CLAIM. PHOTO RECEIVED FROM CUSTOMER WAS EVALUATED. NO DISCREPANCIES OBSERVED. PRODUCT WAS CORRECT AND CORRECTLY IDENTIFIED (CARTRIDGE AND BOX). NO CORRECTIVE ACTION IS REQUIRED BASED ON INFORMATION EVALUATED AND SATISFACTORY RESULTS OBTAINED DURING THE QC TEST. 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.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A COMPLAINT INVESTIGATION, DUE TO DIFFERENT CATALOG LABELING ON THE INTERNAL PACKAGING ON CEFTAZIDIME CATALOG 231633 BATCH 4156643, WAS PERFORMED. THE INVESTIGATION REQUIRED TO PERFORM VISUAL INSPECTION, PHOTOS EVALUATION AND BATCH RECORD REVIEW. NO DISCREPANCIES OBSERVED DURING THE VISUAL INSPECTION. RETENTION SAMPLES WERE CORRECT AND CORRECTLY IDENTIFIED (CARTRIDGE AND BOX). RETURNED GOODS WERE NOT RECEIVED FOR THE INVESTIGATION. BATCH RECORD REVIEW DID NOT SHOW ANY EVIDENCE OF CUSTOMER CLAIM. PHOTO RECEIVED FROM CUSTOMER WAS EVALUATED. NO DISCREPANCIES OBSERVED. PRODUCT WAS CORRECT AND CORRECTLY IDENTIFIED (CARTRIDGE AND BOX). CATALOG NUMBER REFERENCED IN THE CARTRIDGE LABEL IS USED FOR PRODUCT CONFIGURATION OF SINGLE AND TEN PACK PACKAGING. FOR TEN PACK CONFIGURATION THE BOX LABEL WILL INCLUDE A DIFFERENT CATALOG NUMBER. SINCE CATALOG 231633 IS A TEN PACK, IT WILL HAVE A DIFFERENT CATALOG NUMBER IN THE BOX LABEL, WHEN COMPARED WITH THE CATALOG NUMBER REFERENCED IN THE CARTRIDGE LABEL. NO CORRECTIVE ACTION IS REQUIRED BASED ON INFORMATION EVALUATED AND SATISFACTORY RESULTS OBTAINED DURING THE QC TEST. 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 PRIOR TO USING THE BD BBL¿ SENSI-DISC¿ CEFTAZIDIME 30 ¿G, THE USER NOTED THAT THE LABEL OF THE CARTRIDGE CONTAINING THE PRODUCT (INTERNAL LABELING) WAS DIFFERENT FROM THE SHELF PACKAGE LABEL (EXTERNAL LABEL). NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USING THE BD BBL¿ SENSI-DISC¿ CEFTAZIDIME 30 G, THE USER NOTED THAT THE LABEL OF THE CARTRIDGE CONTAINING THE PRODUCT (INTERNAL LABELING) WAS DIFFERENT FROM THE SHELF PACKAGE LABEL (EXTERNAL LABEL). NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1881021 BD BBL¿ SENSI-DISC¿ CEFTAZIDIME 30 ¿G SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL JTN BECTON DICKINSON CARIBE LTD. 4156643 30382902316337

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown