BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HICKMAN 9.6 FR SINGLE-LUMEN CV CATHETER, PEEL

    MDR report key: 2821010 · Received October 26, 2012

    Report

    Report Number
    3006260740-2012-00382
    Event Type
    Injury
    Date Received
    October 26, 2012
    Date of Event
    August 15, 2012
    Report Date
    October 2, 2012
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K830233
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. THE CATHETER WAS OBSERVED BOTH VISUALLY AND MICROSCOPICALLY. THE CATHETER HAS BROKEN DUE TO EXCESSIVE TENSILE FORCE THAT HAS EXCEEDED THE ELASTIC LIMITS OF THE TUBING. THERE IS A COMPLETE BREAK LOCATED AT THE VITACUFF SLEEVE AND A PARTIAL BRAKE THAT IS LOCATED AT THE JUNCTURE OF THE DISTAL END OF THE COMPRESSION SLEEVE AND THE CATHETER TUBING. THE BROKEN ROUNDED EDGES AND GRANULAR VENEER ON EACH OF THE BROKEN ENDS OF THE COMPLAINT SAMPLE ARE TRAITS THAT ARE CONSISTENT WITH A BREAK IN THE TUBING IN WHICH THE ELASTIC STRENGTH OF THE CATHETER HAS BEEN EXCEEDED. GROSS VISUAL AND MICROSCOPIC EXAMINATION SHOWS NO EVIDENCE OF A DEFECT OR DEFORMITY RELATED TO THE MANUFACTURING PROCESS. THE COMPLAINANT INDICATES THE DEVICE BROKE DURING REMOVAL. NO EVIDENCE OF A MANUFACTURING DEFECT OR DEFORMITY WAS IDENTIFIED. THE PRODUCT INSTRUCTIONS FOR USE (IFU) CAUTIONS THE USER TO MINIMIZE THE RISK OF CATHETER BREAKAGE. EXCESSIVE PULLING OF THE CATHETER SHOULD BE AVOIDED IN ORDER TO AVERT DAMAGE TO THE SILICONE MATERIAL. THE PRODUCT IFU GIVES GRAPHIC AND ILLUSTRATED INSTRUCTIONS ON PROPER REMOVAL TECHNIQUES AND REMOVAL OF THE CATHETER. ACCORDING TO THE PRODUCT IFU TWO TECHNIQUES ARE RECOMMENDED. THE METHOD USED WILL DEPEND UPON THE PHYSICIAN PREFERENCE AND THE AMOUNT OF TISSUE/CUFF INGROWTH THAT IS PRESENT. A LOT HISTORY REVIEW (LHR) OF HUUJ1670 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    WHILE REMOVING THE SL HICKMAN, IT CAME APART AT ITS ATTACHMENT BEFORE THE CUFF. THE CUFF KEPT THE REST OF THE SL IN PLACE, AND WE REMOVED IT SAFELY FORM A MORE PROXIMAL DERMATOTOMY. THE CATHETER DID NOT FRACTURE, IT JUST CAME UNDONE AT THE CONNECTION BEFORE THE CUFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HICKMAN 9.6 FR SINGLE-LUMEN CV CATHETER, PEEL LJS C.R. BARD, INC. (BASD) HUUJ1670

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention