BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ SENSI-DISC¿ PENICILLIN - 10 UNITS

    MDR report key: 14350136 · Received May 10, 2022

    Report

    Report Number
    2647876-2022-00135
    Event Type
    Malfunction
    Date Received
    May 10, 2022
    Date of Event
    April 14, 2022
    Report Date
    May 24, 2022
    Manufacturer
    BECTON DICKINSON CARIBE LTD.
    Product Code
    JTN
    UDI-DI
    00382902313212
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    INVESTIGATION SUMMARY: A COMPLAINT INVESTIGATION DUE TO FAILURE TO INHIBIT THE GROWTH OF S. EPIDERMIDIS OR M. LUTEUS FOR PENICILLIN CATALOG 231321 BATCH NO.: 1085651 WAS PERFORMED ON RETENTION SAMPLES. RETURNED GOODS WERE NOT RECEIVED FROM CUSTOMER. THE INVESTIGATION REQUIRED TO PERFORM BAUER KIRBY TEST, VISUAL INSPECTION, AND BATCH RECORD REVIEW. RETENTION SAMPLES PERFORMED AS EXPECTED. REFER TO RESULTS BELOW. 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. COMPLAINT IS NOT CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ SENSI-DISC¿ PENICILLIN - 10 UNITS THE CUSTOMER OBSERVED A PERFORMANCE ISSUE INVOLVING FAILURE TO INHIBIT BIOLOGICAL GROWTH. THIS EVENT OCCURRED 1 TIME(S). THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS THE FOLLOWING: BD BBL SENSI-DISC #231321 PENICILLIN DISCS, LOT 1085651, FAILED TO INHIBIT THE GROWTH OF S. EPIDERMIDIS OR M. LUTEUS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD BBL¿ SENSI-DISC¿ PENICILLIN - 10 UNITS THE CUSTOMER OBSERVED A PERFORMANCE ISSUE INVOLVING FAILURE TO INHIBIT BIOLOGICAL GROWTH. THIS EVENT OCCURRED 1 TIME(S). THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTS THE FOLLOWING: BD BBL SENSI-DISC #231321 PENICILLIN DISCS, LOT 1085651, FAILED TO INHIBIT THE GROWTH OF S. EPIDERMIDIS OR M. LUTEUS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915105 BD BBL¿ SENSI-DISC¿ PENICILLIN - 10 UNITS SUSCEPTIBILITY TEST DISCS, ANTIMICROBIAL JTN BECTON DICKINSON CARIBE LTD. 1085651 00382902313212

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown