BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GROSHONG 3F SINGLE-LUMEN PICC BASIC TRAY WITH SAFETY INTRO

    MDR report key: 3831918 · Received March 6, 2014

    Report

    Report Number
    3006260740-2014-00102
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    November 13, 2013
    Report Date
    February 13, 2014
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K926331
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER AT THIS TIME, FOR EVAL. A LOT HISTORY REVIEW (LHR) OF REVB0467 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    "IT WAS REPORTED THAT CATHETER PRESENTED HOLE AROUND 20CM MARK IN THE MOMENT OF ITS INSERTION. IT WAS DONE THE PREVIOUS TEST TO CHECK THE LEAKING AND IT WAS NOTED ANY PROBLEM. HOWEVER, WHEN PINCHING THE CATHETER TIP IT'S SEEN THE ORIFICE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135957 GROSHONG 3F SINGLE-LUMEN PICC BASIC TRAY WITH SAFETY INTRO LJS C.R. BARD, INC. (BASD) REVB0467

    Patients

    Seq Age Sex Outcome Treatment
    1