BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 3-LUMEN 8.5FR X 20CM

    MDR report key: 3190545 · Received June 21, 2013

    Report

    Report Number
    3006425876-2013-00114
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 18, 2013
    Report Date
    June 21, 2013
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DQO
    PMA / PMN Number
    K862056
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED, WHILE IN THE ICU THE DISTAL EXTENSION LINE WAS TORN. THE PT HAD A 3-WAY CVC INSERTED INTO HIS LEFT SUBCLAVIAN FOR ABOUT 15 DAYS. THE CATHETER WAS ATTACHED TO THE SKIN WITH SUTURES. WHILE THE PT WAS IN HIS CHAIR, HE FELL FORWARD. IT WAS THEN FOUND THAT THE DISTAL LUMEN WAS CUT ON THE TUBING BETWEEN THE CONNECTOR AND THE JUNCTURE HUB. THE DISTAL LUMEN WAS IMMEDIATELY CLAMPED TO PREVENT AIR EMBOLISM AND WAS THEN REMOVED. IT IS UNK IF A NEW CATHETER WAS PLACED OR IF THERE WAS A DELAY IN TREATMENT. NO COMPLICATIONS OR DEATH OCCURRED TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283558 CVC SET: 3-LUMEN 8.5FR X 20CM ADULT MULTI-LUMEN CATHETER PRODUCTS DQO ARROW INTERNATIONAL INC ZF3037980

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK