BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPICC SOLO CATHETER WITH SHERLOCK 3CG

    MDR report key: 14461973 · Received May 20, 2022

    Report

    Report Number
    3006260740-2022-01872
    Event Type
    Malfunction
    Date Received
    May 20, 2022
    Date of Event
    April 26, 2022
    Report Date
    June 24, 2022
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    LJS
    PMA / PMN Number
    K091324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF REFW4363 SHOWED FIVE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    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 REPORT WAS SUBMITTED, UPON FURTHER REVIEW IT WAS FOUND THAT THIS MEDWATCH REPORT 3006260740-2022-01872 IS A DUPLICATE FILE AND HAS BEEN VOIDED. THE ORIGINAL EVENT WAS SUBMITTED ON MEDWATCH REPORT 3006260740-2022-01870.

    Description of Event or Problem · 0

    IT WAS REPORTED POWERPICC SOLO INSERTED 220118, AT THE HEALTH CARE CENTER THE HAD A LEAKAGE/HOLE IN THE CATHETER DURING CARE AND MAINTENANCE. THE DAMAGE/LEAKAGE IS LOCATED BELOW THE FASTENING/WINGS WHERE THE CATHETER ENTER INTO THE WINGS.

    Description of Event or Problem · 0

    IT WAS REPORTED POWERPICC SOLO INSERTED 220118, AT THE HEALTH CARE CENTER THE HAD A LEAKEAGE/HOLE IN THE CATHETHER DURING CARE AND MAINTANCE. THE DAMAGE/LEAKAGE IS LOCATED BELOW THE FASTENING/WINGS WHERE THE CATHETER ENTER INTO THE WINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552327 POWERPICC SOLO CATHETER WITH SHERLOCK 3CG CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS C.R. BARD, INC. (BASD) -3006260740 N/A REFW4363

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other