BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMODIALYSIS KIT: 2-L 15 FR X 19 CM

    MDR report key: 4213616 · Received October 24, 2014

    Report

    Report Number
    1036844-2014-00433
    Event Type
    Malfunction
    Date Received
    October 24, 2014
    Date of Event
    October 2, 2014
    Report Date
    October 23, 2014
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    MSD
    PMA / PMN Number
    K111117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN NEPHROLOGY, THE DOCTOR DID DIALYSIS FOR THE PT (B)(6) 2014. AFTER THE CATHETER WAS SUCCESSFULLY INSERTED INTO THE PT'S SUBCLAVIAN VEIN, A SLIGHT BLOOD LEAK WAS FOUND ON THE BLUE CONNECTOR. AS THE DOCTOR THOUGHT IT WOULD NOT AFFECT USAGE, THE CATHETER WAS LEFT INSITU. DURING THE NEXT FEW DIALYSES, THE LEAK CONTINUED TO OCCUR AND WHEN THE DOCTOR CHECKED THE CATHETER, HE FOUND A CRACK ON THE BLUE LUER HUB. AS A RESULT OF THE FINDING, THE CATHETER WAS REMOVED AND REPLACED WITH A NEW KIT TO SUCCESSFULLY PROCEED WITH THE SURGERY. THERE WAS NO REPORTED DELAY, DEATH, OR COMPLICATIONS TO THE PT AS A RESULT OF THIS OCCURRENCE. THE USER NOTED THAT THE PRODUCT WAS CONTAMINATED AND AS A RESULT WILL NOT BE RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678632 HEMODIALYSIS KIT: 2-L 15 FR X 19 CM CHRONIC HEMODIALYSIS CATHETER MSD ARROW INTERNATIONAL INC. 23F13L0118

    Patients

    Seq Age Sex Outcome Treatment
    1