BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSION ADAPTER C100

    MDR report key: 10738495 · Received October 26, 2020

    Report

    Report Number
    3003152976-2020-00472
    Event Type
    Malfunction
    Date Received
    October 26, 2020
    Date of Event
    September 30, 2020
    Report Date
    December 3, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    ONB
    UDI-DI
    00382905153068
    PMA / PMN Number
    K123213
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOTS 1910107, 1911105, 2001110 AND 2002104, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THREE RETAINED SAMPLES OF EACH LOT WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS VISUALLY INSPECTED AND NO DEFECTS WERE IDENTIFIED AND THE CAPS WAS SECURE. PRODUCT UNDERGOES VISUAL AND FUNCTIONAL TESTING THROUGHOUT MANUFACTURING TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE. SINCE DHR REVIEWED AND LOT RELEASE TESTING DID NOT INDICATE ANY DEVIATIONS, AND RESULTS OF TEST PERFORMED ON RETAINED SAMPLES REQUESTED PERFORMED AS INTENDED, THE EVENT REPORTED COULD NOT BE REPLICATED AND IT IS NOT POSSIBLE TO IDENTIFY ROOT CAUSE FOR THE ISSUE AT THIS TIME. COMPLAINTS FOR THIS ISSUE WILL CONTINUED TO BE MONITORED AND TRACKED FOR TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 INFUSION ADAPTERS C100 HAD A MISSING END CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LATELY THE PROTECTIVE "FLIP CAPS" THAT COVER THE END OF THE C100 OPEN POST COMPOUNDING DURING THE PACKAGING PROCESS LATELY THE PROTECTIVE "FLIP CAPS" THAT COVER THE END OF THE C100 OPEN POST COMPOUNDING DURING THE PACKAGING PROCESS. DAVID IS FINDING OUT HOW THESE EVENTS HAVE BEEN OCCURRING AS WELL AS THE LOT NUMBERS."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1910107, MEDICAL DEVICE EXPIRATION DATE: 2023-09-30, DEVICE MANUFACTURE DATE: 2019-10-31. MEDICAL DEVICE LOT #: 1911105, MEDICAL DEVICE EXPIRATION DATE: 2023-10-31, DEVICE MANUFACTURE DATE: 2019-11-27. MEDICAL DEVICE LOT #: 2001110, MEDICAL DEVICE EXPIRATION DATE: 2023-12-31, DEVICE MANUFACTURE DATE: 2020-02-04. MEDICAL DEVICE LOT #: 2002104, MEDICAL DEVICE EXPIRATION DATE: 2024-01-31, DEVICE MANUFACTURE DATE: 2020-02-24. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 4 INFUSION ADAPTERS C100 HAD A MISSING END CAP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LATELY THE PROTECTIVE "FLIP CAPS" THAT COVER THE END OF THE C100 OPEN POST COMPOUNDING DURING THE PACKAGING PROCESS LATELY THE PROTECTIVE "FLIP CAPS" THAT COVER THE END OF THE C100 OPEN POST COMPOUNDING DURING THE PACKAGING PROCESS. (B)(6) IS FINDING OUT HOW THESE EVENTS HAVE BEEN OCCURRING AS WELL AS THE LOT NUMBERS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1203069 INFUSION ADAPTER C100 INTRAVASCULAR ADMINISTRATION SET ONB BECTON DICKINSON, S.A. 515306 SEE H.10. 00382905153068

    Patients

    Seq Age Sex Outcome Treatment
    1 Other