BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC KIT: 3-LUMEN 12 FR X 16 CM

    MDR report key: 1994251 · Received January 14, 2011

    Report

    Report Number
    1036844-2011-00013
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    January 3, 2011
    Report Date
    January 12, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DQO
    PMA / PMN Number
    K900263
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THEY WERE TRANSFERRING A MALE PT WITH A CENTRAL VENOUS CATHETER IN HIS INTERNAL JUGULAR FROM THE BED TO THE OPERATING ROOM (OR) TABLE WHEN THE DISTAL HUB OF THE CATHETER BROKE OFF AND FLEW ACROSS THE ROOM. THEY COULD NOT FIND IT. THE PT CAME TO THE OPERATING ROOM WITH THE CATHETER ALREADY IN PLACE. AS A RESULT, THEY HAD TO DO AN OVER-THE-WIRE EXCHANGE BEFORE THEY COULD CONTINUE WITH THE CASE. THERE WAS A 30 MINUTE DELAY IN TREATMENT, NO PT DEATH AND NO PT COMPLICATIONS WERE REPORTED. ADD'L INFO RECEIVED FROM THE MEDICAL SALES REP STATED THE PT OUTCOME WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC KIT: 3-LUMEN 12 FR X 16 CM ARROWG+ARD CATHETER PRODUCTS. DQO ARROW INTERNATIONAL INC RF0116444

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK