BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALLBORE EXTENSION SET

    MDR report key: 9857983 · Received March 19, 2020

    Report

    Report Number
    9616066-2020-01079
    Event Type
    Malfunction
    Date Received
    March 19, 2020
    Date of Event
    August 1, 2019
    Report Date
    February 28, 2020
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    UDI-DI
    10885403234903
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: B4 AND G4 DATE CHANGED TO 28FEB2020.

    Description of Event or Problem · 0

    CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "NOTED LEAKING AT CONNECTOR BETWEEN BD MAXZERO EXTENSION SET AND CAREFUSION MICROBORE TRI-FUSE EXTENSION SET WITH MAX ZERO CONNECTOR.."

    Description of Event or Problem · 0

    CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "NOTED LEAKING AT CONNECTOR BETWEEN BD MAXZERO EXTENSION SET AND CAREFUSION MICROBORE TRI-FUSE EXTENSION SET WITH MAX ZERO CONNECTOR.."

    Additional Manufacturer Narrative · 1

    NO PRODUCT WILL BE RETURNED PER CUSTOMER. THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED BECAUSE THE PRODUCT WAS NOT SEQUESTERED FOR FAILURE INVESTIGATION. THE ROOT CAUSE OF THIS FAILURE WAS NOT IDENTIFIED.

    Description of Event or Problem · 1

    CUSTOMER ADVOCACY RECEIVED A COPY OF THE CUSTOMER'S MEDWATCH REPORT FROM THE FDA WHICH STATES, "NOTED LEAKING AT CONNECTOR BETWEEN BD MAXZERO EXTENSION SET AND CAREFUSION MICROBORE TRI-FUSE EXTENSION SET WITH MAX ZERO CONNECTOR.." AN INCOMPLETE DATE OF EVENT OF (B)(6) 2019 WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321024 SMALLBORE EXTENSION SET SET, EXTENSION, INTRAVASCULAR FPA CAREFUSION 20129E 10885403234903

    Patients

    Seq Age Sex Outcome Treatment
    1 8100,PRI TUBING,8015,THERAPY DATE UNK