BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPICC HF CATHETER 5F FULL TRAY (TRIPLE-LUMEN)

    MDR report key: 10583563 · Received September 24, 2020

    Report

    Report Number
    3006260740-2020-03358
    Event Type
    Malfunction
    Date Received
    September 24, 2020
    Date of Event
    August 22, 2020
    Report Date
    November 9, 2020
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    UDI-DI
    00801741028168
    PMA / PMN Number
    K053501
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. INITIAL MEDWATCH WAS SUBMITTED AS A SECOND EVENT, UPON FURTHER INFORMATION IT WAS FOUND THAT THIS REPORTED IS A CASCADING EVENT OF MEDWATCH REPORT SUBMITTED UNDER REPORT NUMBER 3006260740-2020-03356.

    Description of Event or Problem · 0

    IT WAS REPORTED: "8/22 @ 0756, DRESSING CHANGED DUE TO LEAKING AND LIFTING UP ALONG THE SIDE. 8/22 @ 1300, VASCULAR ACCESS TEAM CALLED TO ASSESS PICC DUE TO PERSISTENT LEAKING; LEAKING WAS NOTED FROM THE INSERTION SITE, CATHETER SLOWLY PULLED BACK WITH FLUSHING AND FRACTURE NOTED A FEW CENTIMETERS DOWN ON THE INTERNAL SEGMENT OF THE CATHETER." "PLACEMENT INFO: 5 FR TRIPLE LUMEN PROVENA POWERPICC PLACED IN THE RIGHT UPPER ARM, BRACHIAL VEIN. 12 CM EXTERNAL LENGTH; SECURACATH IN PLACE" NO PT HARM REPORTED

    Additional Manufacturer Narrative · 1

    THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL EVALUATE. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) OF REDV2044 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED: "8/22 @ 0756, DRESSING CHANGED DUE TO LEAKING AND LIFTING UP ALONG THE SIDE. 8/22 @ 1300, VASCULAR ACCESS TEAM CALLED TO ASSESS PICC DUE TO PERSISTENT LEAKING; LEAKING WAS NOTED FROM THE INSERTION SITE, CATHETER SLOWLY PULLED BACK WITH FLUSHING AND FRACTURE NOTED A FEW CENTIMETERS DOWN ON THE INTERNAL SEGMENT OF THE CATHETER." "PLACEMENT INFO: 5 FR TRIPLE LUMEN PROVENA POWERPICC PLACED IN THE RIGHT UPPER ARM, BRACHIAL VEIN. 12 CM EXTERNAL LENGTH; SECURACATH IN PLACE" NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1046506 POWERPICC HF CATHETER 5F FULL TRAY (TRIPLE-LUMEN) CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS BARD ACCESS SYSTEMS N/A REDV2044 00801741028168

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR