BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPICC PROVENA CATHETER WITH SOLO VALVE TECHNOLOGY

    MDR report key: 11049377 · Received December 21, 2020

    Report

    Report Number
    3006260740-2020-21015
    Event Type
    Malfunction
    Date Received
    December 21, 2020
    Date of Event
    December 1, 2020
    Report Date
    December 7, 2020
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    UDI-DI
    00801741112744
    PMA / PMN Number
    K072230
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    IT WAS REPORTED A 5FR. PROVENA TRIPLE PICC MIGRATED TO THE NECK. ADDITIONAL INFO. RECEIVED 12/09/2020. "THE PICC LINE THAT ARRIVED WITH THE PICC IN THE RIGHT IJ. PICC WAS FLUSHED OUT OF THE IJ BY THE STAFF AND THE LINE WAS MID-SVC, NOT CAJ."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1517620 POWERPICC PROVENA CATHETER WITH SOLO VALVE TECHNOLOGY CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS C.R. BARD, INC. (BASD) -3006260740 N/A UNKNOWN 00801741112744

    Patients

    Seq Age Sex Outcome Treatment
    1 Other