BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERGLIDE MIDLINE CATHETER 20G,. 8CM FULL INSERTION KIT

    MDR report key: 3242411 · Received July 18, 2013

    Report

    Report Number
    3006260740-2013-00351
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    May 19, 2013
    Report Date
    June 26, 2013
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    FOZ
    PMA / PMN Number
    K121073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF A BREAK IN THE CATHETER IS CONFIRMED. GROSS AND MICROSCOPIC EXAM OF THE COMPLAINT SAMPLE REVEALS A PARTIAL BREAK IN THE QUADRAFLEX CATHETER MATERIAL. MAGNIFIED VIEWS OF THE BREAK SITE SHOWS AN IRREGULAR EDGE WITH A BROKEN AND ROUGH VENEER OVER APPROX ONE HALF OF THE CIRCUMFERENCE OF THE DISTAL EDGE. THESE TRAITS INDICATE THE DAMAGE IS A RESULT OF A BREAK IN THE TUBING. THE REMAINDER OF THE CIRCUMFERENCE HAS A ROUNDED EDGE WITH A GLOSSY, SMOOTH VENEER. IT IS POSSIBLE THE BREAK MANIFESTED ITSELF AFTER THE CATHETER WAS PARTIALLY PERFORATED OR CUT BY THE INTRODUCER NEEDLE. IT SHOULD BE NOTED THAT REINSERTION OR MANIPULATION OF THE NEEDLE DURING THE PLACEMENT PROCEDURE AND HAS THE POTENTIAL TO CAUSE DAMAGE TO THE CATHETER. THE MECHANISM OF THE BREAK IN THE TUBING IS UNDETERMINED. THE PRODUCT INSTRUCTIONS FOR USE (IFU) PROVIDE WRITTEN AND ILLUSTRATED INFORMATION ON PROPER PLACEMENT TECHNIQUES AND TO AVOID CIRCUMSTANCES THAT COULD JEOPARDIZE THE FUNCTIONALITY OF THE CATHETER. A LOT HISTORY REVIEW (LHR) OF REWJ0947 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    REF(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335330 POWERGLIDE MIDLINE CATHETER 20G,. 8CM FULL INSERTION KIT FOZ C. R. BARD INC. (BASD) REWJ0947

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention