BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMODIALYSIS KIT: 2-L 15 FR X 28 CM

    MDR report key: 1832054 · Received September 3, 2010

    Report

    Report Number
    1036844-2010-00272
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    May 26, 2010
    Report Date
    September 2, 2010
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    MSD
    PMA / PMN Number
    K040078
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVAL: ONE PEEL-AWAY SHEATH WAS RETURNED FOR EVAL. THE SHEATH DID NOT PEEL ON ONE OF THE SCORE LINES STARTING AT THE HUB AND EXTENDING 5 CM AT THE DISTAL TIP OF THE SHEATH DID NOT PEEL, BUT HAD ONE SPLIT IN IT. THERE WERE NO RELEVANT FINDINGS IN THE SHEATH INSPECTION RECORDS FOR THIS LOT. THE REPORT OF DIFFICULTY PEELING AWAY THE SHEATH WAS CONFIRMED THROUGH VISUAL INSPECTION OF THE RETURNED SAMPLE. THE POTENTIAL CAUSE OF THIS ISSUE IS SUPPLIER RELATED SINCE THE SHEATH IS A PURCHASED COMPONENT. THIS ISSUE WAS PREVIOUSLY INVESTIGATED BY THE SUPPLIER UNDER A SCAR AND CORRECTIVE ACTION WAS TAKEN 03/27/2009. THE SAMPLE ON THIS COMPLAINT WAS MFG BEFORE THE CORRECTIVE ACTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PEEL-AWAY SHEATH DOES NOT SPLIT PROPERLY. THE RESULT IS THE SHEATH IS SPLITTING TO THE SIDE OF THE MARKINGS. THERE IS NO FURTHER INFO ON THIS EVENT. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. THERE WAS NO CONSEQUENCE TO THE PT. THERE WAS NO REPORTED PT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEMODIALYSIS KIT: 2-L 15 FR X 28 CM CHRONIC HEMODIALYSIS CATHETER PRODUCTS MSD ARROW INTERNATIONAL INC. RF9055374

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK