BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPICC 4F SL KIT W/BIOPATCH, PROBE COVER & BELDAR NEEDLE GUIDES

    MDR report key: 21180999 · Received January 17, 2025

    Report

    Report Number
    3006260740-2025-00020
    Event Type
    Malfunction
    Date Received
    January 17, 2025
    Date of Event
    December 9, 2024
    Report Date
    February 26, 2025
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    UDI-DI
    00801741155147
    PMA / PMN Number
    K070996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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. THE COMPLAINT OF A KINKED CATHETER WAS UNCONFIRMED AS THE PROBLEM COULD NOT BE REPRODUCED. A SINGLE RADIOGRAPHIC IMAGE OF A PATIENT¿S RIGHT-SIDE HUMERUS WAS RETURNED FOR EVALUATION. A CATHETER, CONSISTENT WITH THE IMPLICATED 4FR S/L POWERPICC, WAS PRESENT. THE IMAGE SHOWED OVERLAPPING OF THE CATHETER TUBING BUT DID NOT SHOW DEFINITIVE BENDING, KINKING, OR LOOPING. THIS COMPLAINT WILL BE RECORDED FOR FUTURE TRENDING AND MONITORING PURPOSES.

    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. THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. A SUPPLEMENTAL WILL BE SUBMITTED WITH EVALUATION RESULTS.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT 12/9/24 HUMERUS X-RAY SHOWS KINK. OSH 4 FR SL POWER PICC NO LOT NUMBER AS OSH. 12/10/24 OWX 5FR TL POWER PICC. NO OTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT ON (B)(6) 2024 HUMERUS X-RAY SHOWS KINK. OSH 4 FR SL POWER PICC NO LOT NUMBER AS OSH. ON (B)(6) 2024, OWX 5FR TL POWER PICC. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907890 POWERPICC 4F SL KIT W/BIOPATCH, PROBE COVER & BELDAR NEEDLE GUIDES CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS C.R. BARD, INC. (BASD) -3006260740 N/A UNKNOWN 00801741155147

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other