BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM

    MDR report key: 14312973 · Received May 6, 2022

    Report

    Report Number
    3006425876-2022-00392
    Event Type
    Malfunction
    Date Received
    May 6, 2022
    Date of Event
    March 14, 2022
    Report Date
    April 14, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    MPB
    PMA / PMN Number
    K993933
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED A SINGLE GUIDE WIRE AND DILATOR. THE RETURNED COMPONENTS SHOWED EVIDENCE OF USE. THE GUIDE WIRE WAS OBSERVED TO HAVE A SEVERAL KINKS/BENDS IN ITS BODY. THE DISTAL J-BEND WAS SLIGHTLY MISSHAPEN BUT INTACT. MICROSCOPIC EXAMINATION CONFIRMED THE KINKS IN THE GUIDE WIRE BODY. BOTH WELDS WERE PRESENT AND WERE OBSERVED TO BE FULL AND SPHERICAL. THE KINKS IN THE GUIDE WIRE WERE LOCATED 331 MM, 358 MM, AND 388 MM FROM THE PROXIMAL TIP. THE OVERALL LENGTH OF THE GUIDE WIRE MEASURED 599 MM WHICH IS WITHIN THE SPECIFICATION OF 596-604 MM PER GUIDE WIRE PRODUCT DRAWING. THE OUTER DIAMETER OF THE GUIDE WIRE MEASURED 0.857 MM WHICH IS WITHIN THE SPECIFICATION OF 0.838-0.877 MM PER GUIDE WIRE PRODUCT DRAWING. SIMULATED USE OF THE GUIDE WIRE WAS PERFORMED PER THE INSTRUCTIONS FOR USE (IFU) PROVIDED WITH THIS KIT WHICH STATES, "USING THE TWO-PIECE ARROW ADVANCER, ADVANCE SPRING-WIRE GUIDE THROUGH SYRINGE INTO VEIN." THE GUIDE WIRE WAS ADVANCED THROUGH A LAB INVENTORY ARS AND A LAB INVENTORY 18GA INTRODUCER NEEDLE TO FUNCTIONALLY TEST THE GUIDE WIRE. THE UNDAMAGED PORTIONS OF THE GUIDE WIRE PASSED THROUGH BOTH COMPONENTS WITH MINIMAL RESISTANCE. THE GUIDE WIRE WAS ALSO ADVANCED THROUGH THE RETURNED DILATOR WITH MINIMAL RESISTANCE. A MANUAL TUG TEST CONFIRMED THAT BOTH THE DISTAL AND PROXIMAL WELDS WERE INTACT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. THE INSTRUCTIONS-FOR-USE (IFU) PROVIDED WITH THE KIT DESCRIBES SUGGESTED TECHNIQUES TO MINIMIZE THE LIKELIHOOD OF GUIDE WIRE DAMAGE DURING USE. THE INSTRUCTIONS CAUTION THAT WITHDRAWING THE GUIDE WIRE AGAINST THE NEEDLE BEVEL OR USE OF EXCESSIVE FORCE DURING REMOVAL COULD DAMAGE OR BREAK THE WIRE. THE REPORT THAT THE GUIDE WIRE KINKED DURING USE WAS CONFIRMED THROUGH EXAMINATION OF THE RETURNED SAMPLE. THE GUIDE WIRE WAS KINKED IN SEVERAL LOCATIONS THROUGHOUT THE BODY. THE RETURNED GUIDE WIRE MET ALL RELEVANT DIMENSIONAL REQUIREMENTS AND A DEVICE HISTORY RECORD REVIEW DID NOT IDENTIFY ANY MANUFACTURING RELATED ISSUES. BASED ON THE CONDITION OF THE GUIDE WIRE AND THE REPORT THAT THE DAMAGE WAS OBSERVED DURING USE , UNINTENTIONAL USE ERROR CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE SPRING WIRE GUIDE IS KINKED. NO PATIENT HARM REPORTED. THE DEVICE WAS REPLACED. THE PATIENT'S CONDITION IS FINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE SPRING WIRE GUIDE IS KINKED. NO PATIENT HARM REPORTED. THE DEVICE WAS REPLACED. THE PATIENT'S CONDITION IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1213839 ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM CATHETER HEMODIALYTSIS NON IMP MPB ARROW INTERNATIONAL LLC 71F20A2447

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown