BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 3-LUMEN 7FR X 3 0CM

    MDR report key: 2061541 · Received March 16, 2011

    Report

    Report Number
    3006425876-2011-00020
    Event Type
    Malfunction
    Date Received
    March 16, 2011
    Date of Event
    December 23, 2010
    Report Date
    March 11, 2011
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT WAS INITIALLY EVALUATED AND DETERMINED TO BE NON-REPORTABLE. THE RETURNED DEVICE WAS EVALUATED AND THE EVENT WAS DETERMINED TO BE A RESULT OF A PRODUCT MALFUNCTION, THEREFORE IT IS REPORTABLE. DEVICE EVAL: ONE ASR/INTRODUCER NEEDLE ASSEMBLY AND ONE SWG WAS RETURNED FOR EVAL. THE SWG WAS VISUALLY EXAMINED AND A BEND WAS OBSERVED APPROX 13CM FROM THE DISTAL TIP AND A KINK WAS OBSERVED APPROX 16CM FROM THE PROXIMAL END. THE OUTSIDE DIAMETER WAS MEASURED AND WAS WITHIN SPECIFICATION. A MANUAL TUG TEST WAS PERFORMED TO PULL THE ARS ASSEMBLY OVER THE SWG. THIS WAS COMPLETED WITHOUT DIFFICULTY. AFTER REMOVAL OF THE SWG, TWO MORE KINKS WERE OBSERVED APPROX 30.5CM AND 38CM FROM THE PROXIMAL END. THE CORE WIRE OF THE J TIP DOES NOT APPEAR TO BE ATTACHED TO THE WELD. THE SWG WELDS WERE MICROSCOPICALLY EXAMINED. THE DISTAL CORE WIRE BROKE ADJACENT TO THE DISTAL WELD. VISUAL EXAMINATION WAS PERFORMED ON THE ARS AND INTRODUCER NEEDLE WITH NO OBVIOUS ANOMALIES. A 0.032" SWG FROM INTERNAL INVENTORY WAS USED TO ADVANCE THROUGH THE ARS/INTRODUCER NEEDLE ASSEMBLY WITHOUT DIFFICULTY. THE PRODUCTS' INSTRUCTIONS FOR USE DESCRIBE SUGGESTED TECHNIQUES TO MINIMIZE THE LIKELIHOOD OF SWG DAMAGE DURING USE. THE INSTRUCTIONS CAUTION THAT WITHDRAWING THE SWG AGAINST THE NEEDLE BEVEL OR USE OF EXCESSIVE FORCE DURING REMOVAL COULD DAMAGE OR BREAK THE WIRE. THE DEVICE HISTORY RECORDS FOR THE SWG WERE REVIEWED WITH NO FINDINGS RELEVANT TO THIS COMPLAINT. THE INVESTIGATION FOUND NO EVIDENCE TO SUGGEST A MFG RELATED CAUSE. THE CUSTOMER REPORTED RESISTANCE OF THE SWG AND ARS, WHICH WAS CONFIRMED THROUGH VISUAL AND FUNCTIONAL TESTING OF THE RETURNED SAMPLE. THE CORE WIRE BROKE ADJACENT TO THE WELD. THE SELECTED INSERTION SITE AND PT ANATOMY MAY PRESENT A TORTUOUS PATH THAT COULD CONTRIBUTE TO THE POSSIBILITY OF SWG KINKING. SWG BREAKAGE MAY OCCUR IF A FORCE GREATER THAN THE DESIGN SPECIFICATION IS APPLIED DURING REMOVAL. BASED ON THESE CIRCUMSTANCES, THE POTENTIAL CAUSE OF THIS ISSUE IS PROCEDURE/PT ANATOMY RELATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PLACEMENT OF THIS PRODUCT, THE VEIN WAS PUNCTURED WITH THE NEEDLE AND ARROW RAULERSON SYRINGE (ASR). THE SPRING WIRE GUIDE (SWG) WAS INSERTED SUCCESSFULLY. WHEN THE PHYSICIAN WANTED TO REMOVE THE SYRINGE OVER THE SWG, IT WAS NOT POSSIBLE. HE THEN REMOVED THE SWG AND ASR AS ONE AND SUCCESSFULLY PLACED ANOTHER KIT. THERE WAS NO PT INJURY OR COMPLICATIONS REPORTED. NO PT DEATH AND NO DELAY OF TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 3-LUMEN 7FR X 3 0CM ADULT MULTI-LUMEN CATHETER PRODUCTS DQY ARROW INTERNATIONAL INC. ZF0089057

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK