BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPICC CATHETER, 4F SL 3CG

    MDR report key: 10118563 · Received June 4, 2020

    Report

    Report Number
    3006260740-2020-01958
    Event Type
    Malfunction
    Date Received
    June 4, 2020
    Report Date
    June 4, 2020
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    UDI-DI
    00801741184925
    PMA / PMN Number
    K091324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A LOT HISTORY REVIEW (LHR) OF REDX0525 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION, AS THE DEVICE REMAINS IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA MS&S "PATIENT RECEIVED PICC CK000897 (LOT# REDX0252) LAST TUESDAY. SHE IS RECEIVING DAILY TREATMENT AND REPORTS HER PICC IS SLUGGISH." MS&S SPOKE WITH NURSE AT INFUSION CENTER WHO STATES THE PICC FLUSHED WITHOUT DIFFICULTY AND A BLOOD RETURN IS NOTED. "IT IS JUST A BIT SLOW". THE NURSE STATES THE FACILITY PROTOCOL IN PLACE USES TPA AND DYE STUDIES IF NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583816 POWERPICC CATHETER, 4F SL 3CG CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS BARD ACCESS SYSTEMS N/A REDX0525 00801741184925

    Patients

    Seq Age Sex Outcome Treatment
    1