BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPICC CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET BASIC T

    MDR report key: 10460121 · Received August 27, 2020

    Report

    Report Number
    3006260740-2020-03056
    Event Type
    Malfunction
    Date Received
    August 27, 2020
    Date of Event
    June 15, 2020
    Report Date
    August 27, 2020
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    UDI-DI
    00801741138980
    PMA / PMN Number
    K091324
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF REDW0444 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTS OBSTRUCTION IN THE LUMEN OF CATHETER PICC MSE (POWERPICC 3CG SINGLE LUMEN), IT WAS INSERTED ON (B)(6) 2020 AND PATIENT REQUIRES TO RECEIVE MEDICATION THROUGH INTRAVENOUS TILL (B)(6) 2020. IT WAS REQUIRED TO REMOVE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    924684 POWERPICC CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET BASIC T CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS BARD ACCESS SYSTEMS N/A REDW0444 00801741138980

    Patients

    Seq Age Sex Outcome Treatment
    1