BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPICC HF CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET

    MDR report key: 10548276 · Received September 17, 2020

    Report

    Report Number
    3006260740-2020-03290
    Event Type
    Malfunction
    Date Received
    September 17, 2020
    Date of Event
    March 18, 2020
    Report Date
    September 17, 2020
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    UDI-DI
    00801741096327
    PMA / PMN Number
    K091324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF REDS2389 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA MEDWATCH "FLUSHED LUMEN (GREY) OF PICC LINE, FLUSHING PRESSURE APPEARED TO HAVE A RUPTURED PICC LINE; VESSEL WAS INTACT". ADDITIONAL INFO RCVD 09/08/2020: UPON FLUSHING RUPTURED APPROXIMATELY 25CM BEYOND INSERT AT JCT OF BASILIC, BRACHIAL AND CEPHALIC VEINS IN SHOULDER NEAR SUBCLAVIAN VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1012140 POWERPICC HF CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS BARD ACCESS SYSTEMS N/A REDS2389 00801741096327

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR