BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPICC SHRELOCK 4F SINGLE-LUMEN POLYURETHANE CATHETER

    MDR report key: 3162449 · Received June 6, 2013

    Report

    Report Number
    3006260740-2013-00285
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Report Date
    May 21, 2013
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K070996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT OF A SUBCUTANEOUS LEAK IN THE CATHETER IS CONFIRMED. DURING FUNCTIONAL TESTING A SPRAYING LEAK WAS OBSERVED EMANATING FROM THE CATHETER. THE LEAK SITE IS LOCATED AT THE 7 CM DEPTH MARK. A LONGITUDINAL SPLIT IN THE CATHETER IS OBSERVED. THE LEAK SITE IS <0.3 INCHES IN LENGTH. THE SPLIT EDGES ARE SHARP AND TRAVERSE IN A STRAIGHT LINE. NO OD DAMAGE TO THE CATHETER IS NOTED. THE TUBING SURROUNDING THE LEAK SITE IS UNREMARKABLE. AT THIS TIME THE MECHANISM OF DAMAGE IS UNDETERMINED. GROSS VISUAL, MICROSCOPIC AN FUNCTIONAL TESTING SHOWS NO EVIDENCE OF A DEFECT OR DEFORMITY RELATED TO THE MANUFACTURING PROCESS. THE PRODUCT INSTRUCTIONS FOR USE (IFU) INSTRUCTS THE USER OF THE FOLLOWING WARNINGS: DO NOT USE A SYRINGE SMALL THAN 10 ML. EXCEEDING THE MAXIMUM FLOW RATE OF (B)(4) OR THE MAXIMUM PRESSURE OF POWER INJECTORS OF (B)(4) MAY RESULT IN CATHETER FAILURE AND/OR CATHETER TIP DISPLACEMENT. FAILURE TO ENSURE PATENCY OF THE CATHETER PRIOR TO POWER INJECTION STUDIES MAY RESULT IN CATHETER FAILURE. CATHETERS THAT PRESENT RESISTANCE TO FLUSHING AND ASPIRATION MAY BE PARTIALLY OCCLUDED. DO NOT FLUSH AGAINST RESISTANCE. A LOT HISTORY REVIEW (LHR) IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER INFORMATION HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    PICC LEAKING. HOLE IN LINE. ADDITIONAL INFORMATION: PICC WAS NOTED TO BE LEAKING 10 TO 15 CM FROM INSERTION SITE. NO PATIENT INJURY RESULTED. REQUIRED NEW DEVICE PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250264 POWERPICC SHRELOCK 4F SINGLE-LUMEN POLYURETHANE CATHETER LJS C. R. BARD INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention