BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9857715 · Received March 19, 2020

    Report

    Report Number
    3006260740-2020-00922
    Event Type
    Malfunction
    Date Received
    March 19, 2020
    Date of Event
    January 28, 2020
    Report Date
    March 19, 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 REDR1702 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ATTENDED THE HOSPITAL FOR ANTIBIOTIC THERAPY WITH AN OPEN MSE POWER PICC CLAMP, WITH PRESENCE OF VISIBLE BLOOD IN THE DISTAL EXTENSION OF THE CATHETER. THE CLAMP IS DEFECTIVE, GIVEN THE DIFFICULTY OF CLOSING DUE TO THE NATURE OF THE MATERIAL. IT CAUSED OCCLUSION OF THE CATHETER, BEING NEEDED ITS REMOVAL AND PASSAGE OF A NEW CATHETER. THE DAUGHTER AND PATIENT REPORT NOT HAVING MANIPULATED THE CATHETER AT ANY TIME AND HAVE ALWAYS BEEN ZEALOUS TOWARDS THE DEVICE, FOLLOWING THE NURSING GUIDELINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320202 POWERPICC CATHETER WITH SHERLOCK 3CG TIP POSITIONING SYSTEM (TPS) STYLET BASIC CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS BARD ACCESS SYSTEMS N/A REDR1702 00801741138980

    Patients

    Seq Age Sex Outcome Treatment
    1