BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXT SET 15CM LUER-LOK POWER INJECTABLE

    MDR report key: 8337021 · Received February 13, 2019

    Report

    Report Number
    9610847-2019-00157
    Event Type
    Malfunction
    Date Received
    February 13, 2019
    Date of Event
    January 23, 2019
    Report Date
    March 14, 2019
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K142527
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: NO FINDINGS IN QNS/NCMR/DHR ABOUT THE LOT NUMBER 8242512 WERE FOUND. THE MANUFACTURING PROCESS WAS REVIEWED AND NO POTENTIAL FAILURES WERE IDENTIFIED SINCE ONLY THE Q-SYTE CONNECTORS ARE ASSEMBLED TO THE BD EXTENSION SETS AND THEN PACKAGED IN THE NOGALES MANUFACTURING PROCESS. NO SAMPLE WAS RETURNED FOR THIS PARTICULAR COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A EXT SET 15CM LUER-LOK POWER INJECTABLE HAD LEAKED FROM THE HUB AND SEPARATED WHERE IT ATTACHES TO THE INSYTE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A EXT SET 15CM LUER-LOK POWER INJECTABLE HAD LEAKED FROM THE HUB AND SEPARATED WHERE IT ATTACHES TO THE INSYTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131058 EXT SET 15CM LUER-LOK POWER INJECTABLE CATHETER FPA BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 8242512

    Patients

    Seq Age Sex Outcome Treatment
    1 Other