BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD Q SITE EXTENSION SET

    MDR report key: 1022044 · Received March 31, 2008

    Report

    Report Number
    MW5006057
    Event Type
    Malfunction
    Date Received
    March 31, 2008
    Date of Event
    March 28, 2008
    Report Date
    March 31, 2008
    Manufacturer
    MPS ACACIA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT'S EXTENSION SET AND BD CAP BROKE WHILE ATTACHED TO HIS PICC LINE AND LEAKED TPN ALL OVER PT. PT'S LINE WAS NOT SECURE FOR NON INFECTIOUS ACCESS WHEN EXTENSION BROKE. THE PLASTIC CAP THAT CONNECTS IT TO THE PT'S TUBING IS WHAT BROKE AND CAUSED LEAKAGE. THIS PRODUCT IS CHANGED WEEKLY ON PT AND NEW TUBING/CAP IS ATTACHED TO PT'S LINE. DATES OF USE: 2008. DIAGNOSIS OR REASON FOR USE: CONNECT PICC LINE TUBING TO DRUG IV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD Q SITE EXTENSION SET EXTENSION SET WITH CAP FPA MPS ACACIA C10053

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR