BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERQCATH CATHETER

    MDR report key: 1963472 · Received December 20, 2010

    Report

    Report Number
    3006260740-2010-00376
    Event Type
    Malfunction
    Date Received
    December 20, 2010
    Date of Event
    October 12, 2010
    Report Date
    November 29, 2010
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL. A CHR REVIEW IS NOT POSSIBLE AS NO MFG LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    THE NURSE AT THE BEDSIDE SAID THE LINE "SNAPPED" AT THE HUB. NO OTHER INFO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERQCATH CATHETER PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER LJS C. R. BARD INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention