BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERGLIDE 20G 10CM FULL KIT

    MDR report key: 2850342 · Received November 15, 2012

    Report

    Report Number
    3006260740-2012-00407
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 24, 2012
    Report Date
    October 26, 2012
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    FOZ
    PMA / PMN Number
    K121073
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF A BREAK IN THE CATHETER IS CONFIRMED AND WILL BE REPORTED AS USER RELATED. GROSS AND MICROSCOPIC EXAMINATIONS OF THE COMPLAINT SAMPLE REVEAL A COMPLETE BREAK IN THE TECOFLEX MATERIAL. A SEVERE KINK IN THE CATHETER IS OBSERVED DISTAL TO THE BREAK SITE. IT IS POSSIBLE THE BREAK MANIFESTED ITSELF AFTER THE CATHETER BECAME KINKED. CROSS SECTIONAL VIEWS OF THE BREAK SITE INDICATE THE INTRODUCER NEEDLE PUNCTURED THE CATHETER PRIOR TO BREAKING COMPLETELY DURING THE PLACEMENT PROCEDURE. IT SHOULD BE NOTED THAT REINSERTION OF THE NEEDLE DURING THE PLACEMENT PROCEDURE HAS THE POTENTIAL TO CAUSE DAMAGE TO THE CATHETER. THE PRODUCT INSTRUCTIONS FOR USE (IFU) GIVE WRITTEN AND ILLUSTRATED INFO ON PROPER PLACEMENT TECHNIQUES AND TO AVOID CIRCUMSTANCES THAT COULD JEOPARDIZE THE FUNCTIONALITY OF THE CATHETER. GROSS VISUAL, MICROSCOPIC EXAMINATIONS AND FUNCTIONAL TESTING SHOW NO EVIDENCE OF A DEFECT OR DEFORMITY RELATED TO THE MFG PROCESS. THIS MAY BE A USER TECHNIQUE ISSUE. A LOT HISTORY REVIEW (LHR) OF REWI0695 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    AS PICC NURSE WAS ATTEMPTING TO INSERT 10CM POWER GLIDE IN TO UPPER EXTREMITY, BRACHIAL VEIN WAS ACCESSED W/O ANY DIFFICULTIES. UPON THREADING THE CATHETER, CATHETER KINKED. NURSE ATTEMPTED TO REMOVE THE CATHETER AND REPOSITION IT AND CATHETER BROKE AND > 5CM OF CATHETER WAS LEFT IN PT'S RIGHT UPPER ARM. TOURNIQUET WAS LEFT IN PLACE, PRESSURE WAS HELD AT THE SITE. STAT X-RAY WAS ORDERED OF UPPER EXTREMITY AND SURGEON WAS NOTIFIED. X-RAY REVEALED THAT CATHETER WAS STILL IN UPPER ARM RIGHT BELOW THE TOURNIQUET. PT WAS TAKEN TO VASCULAR LAB, WHERE SURGEON WAS ABLE TO REMOVE THE CATHETER FRAGMENT. PT WAS IN STABLE CONDITION. PT WAS SENT TO VASCULAR LAB FOR CATHETER RETRIEVAL W/O ANY INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POWERGLIDE 20G 10CM FULL KIT FOZ C. R. BARD INC. (BASD) REWI0695

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention