BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASH SPLIT CATHETER

    MDR report key: 424930 · Received October 25, 2002

    Report

    Report Number
    2518902-2002-00182
    Event Type
    Malfunction
    Date Received
    October 25, 2002
    Date of Event
    September 27, 2002
    Report Date
    October 1, 2002
    Manufacturer
    MEDCOMP
    Product Code
    MPB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENOUS PORT (FEMALE LUER) CRACKED. THE CATHETER WAS REPAIRED BY: "5 MIN BETADINE WIPE TO (V) PORT OF CATH. TIP OF (V) LIMB CUT WITH STERILE SCISSORS AND NEW STERILE (V) BETA CAP (PERITONEAL) INSERTED END OF (V) LIMB. NO FURTHER LEAKING OR AIR BUBBLES NOTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASH SPLIT CATHETER HEMODIALYSIS CATHETER MPB MEDCOMP NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention