BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    L-CATH PEEL AWAY

    MDR report key: 12090 · Received March 17, 1994

    Report

    Report Number
    MW1001128
    Event Type
    Malfunction
    Date Received
    March 17, 1994
    Date of Event
    February 15, 1994
    Report Date
    February 15, 1994
    Manufacturer
    LUTHER MEDICAL PRODUCTS, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    CATHETER PLACED 1/27/94. FLUSHING DAILY WITH SALINE FOLLOWED BY HEPARIN. ON 2/10 LEAKAGE NOTED AT HUB/CATHETER CONNECTION. EXTENSION TIGHTENED AND NO FURTHER LEAKAGE. ON 2/15 DURING DRESSING CHANGE, FLUSHING REVEALED TINY HOLE AT SITE WHERE CATHETER CONNECTS TO HUB. THIS IS FOURTH CATHETER THAT HAS LEAKED AT THIS EXACT SITE. (ALSO SEE MW10000601, 1000900 AND 1000901. )

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 L-CATH PEEL AWAY PICC L-CATH DQO LUTHER MEDICAL PRODUCTS, INC. LMP1392

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Other