BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL SENSI-DISC CEFOXITIN - 30 G

    MDR report key: 12104005 · Received July 1, 2021

    Report

    Report Number
    3008352382-2021-00171
    Event Type
    Malfunction
    Date Received
    July 1, 2021
    Date of Event
    June 2, 2021
    Report Date
    June 28, 2021
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    JTN
    UDI-DI
    30382902315910
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A COMPLAINT INVESTIGATION FOR CEFOXITIN BATCH NO.: 0084083 WAS PERFORMED ON RETENTION SAMPLES. PHOTO FROM CUSTOMER WAS RECEIVED AND EVALUATED. NO DISCREPANCIES OBSERVED. CATALOG 231591 BELONGS TO FOX-30. THE INVESTIGATION REQUIRED TO PERFORM VISUAL INSPECTION, AND BATCH RECORD REVIEW. NO DISCREPANCIES OBSERVED DURING THE VISUAL INSPECTION. BATCH RECORD REVIEW DID NOT SHOW ANY EVIDENCE OF CUSTOMER CLAIM. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING 5 BD BBL¿ SENSI-DISC¿ CEFOXITIN - 30 G A MIX OF PRODUCT TYPES IN THE PACKAGE WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PACKAGING WITH PRODUCT 231591 - CARTRIDGES WITH 231590 INSIDE;".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    994957 BD BBL SENSI-DISC CEFOXITIN - 30 G SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL JTN BECTON DICKINSON CARIBE LTD. 231591 0084083 30382902315910

    Patients

    Seq Age Sex Outcome Treatment
    1