BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVC SET: 16 GA X 16 CM

    MDR report key: 1971504 · Received January 21, 2011

    Report

    Report Number
    3006425876-2011-00007
    Event Type
    Injury
    Date Received
    January 21, 2011
    Date of Event
    January 12, 2011
    Report Date
    January 20, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DQY
    PMA / PMN Number
    K820009
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS EVENT INVOLVED A MALE PATIENT THAT WAS FOUND UNCONSCIOUS SITTING IN A CHAIR AND CATHETER BREAKAGE WAS FOUND. THE PATIENT DEVELOPED AN AIR EMBOLISM. AS A RESULT, WHEN THE BREAKAGE WAS DISCOVERED BETWEEN THE BIFURCATION AND LUER CONNECTION THE CATHETER WAS IMMEDIATELY REMOVED FROM THE PATIENT. THE PATIENT WAS TREATED AT THIS MOMENT IN PRESSURIZED CHAMBER ((B)(4) 2011 3 PM CET) BECAUSE OF THE AIR EMBOLISM. THIS PATIENT'S HOSPITAL STAY WAS ALMOST FINISHED AND WAS SOON READY TO GO HOME. THIS INCIDENT MEANS THERE IS NOW A NEED FOR FURTHER CARE. THE PATIENT IS UNCONSCIOUS. THE PATIENT'S OUTCOME REMAINS UNKNOWN. THE HOSPITAL IS INVESTIGATING THE INCIDENT AND MAY MAKE A DECISION NOT TO USE TELEFLEX CVC'S AT ALL, THE ITEM NUMBER INVOLVED OR ANY CATHETER FROM THE SAME BATCH INVOLVED UNTIL THE INCIDENT IS INVESTIGATED. THE DECISION HAS NOT BEEN MADE YET. THE DOCTOR THAT WAS INTERVIEWED CLAIMS THAT THE CAUSE OF THIS INCIDENT MAY BE AS A RESULT OF THE CATHETER THAT BECAME STUCK AND THE PATIENT PULLED THE CATHETER TO GET LOOSE. THE HOSPITAL WILL CONDUCT AN INVESTIGATION TO TRY TO DETERMINE THE CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 16 GA X 16 CM SINGLE LUMEN CVC PRODUCTS DQY ARROW INTERNATIONAL INC ZF9111074

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| O