BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM

    MDR report key: 5084843 · Received September 17, 2015

    Report

    Report Number
    3006425876-2015-00298
    Event Type
    Malfunction
    Date Received
    September 17, 2015
    Date of Event
    August 28, 2015
    Report Date
    September 3, 2015
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    LFJ
    PMA / PMN Number
    K895417
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS FOR THE FIRST IN A SERIES OF CONSECUTIVE PRODUCT ISSUES WITH THE SAME PATIENT. THE SECOND EVENT WAS REPORTED UNDER MDR# 3006425876-2015-00299.

    Additional Manufacturer Narrative · 1

    QN#(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED BECAUSE NO SAMPLE WAS RETURNED FOR ANALYSIS. A REVIEW OF MANUFACTURING RECORDS DID NOT YIELD ANY RELEVANT FINDINGS. THE PROVIDED INSTRUCTIONS DESCRIBE SUGGESTED TECHNIQUES TO MINIMIZE THE LIKELIHOOD OF GUIDE WIRE DAMAGE DURING USE. THE PROBABLE CAUSE COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED AND WITHOUT A SAMPLE. NO FURTHER ACTIONS WILL BE TAKEN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER PASSING THE CATHETER OVER THE GUIDE WIRE, THE GUIDE WIRE WAS DIFFICULT TO WITHDRAW WHICH RESULTED IN "FRAYING." AS A RESULT A NEW KIT WAS OPENED. THERE WAS A DELAY IN TREATMENT. COMPLICATIONS OF BLEEDING AT THE INSERTION SITE WERE REPORTED. NO PATIENT DEATH OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    616078 HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM ACUTE HEMODIALYSIS CATHETER PRODUCTS LFJ ARROW INTERNATIONAL INC. 71F14F0632

    Patients

    Seq Age Sex Outcome Treatment
    1