BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 8IN

    MDR report key: 2193416 · Received July 13, 2011

    Report

    Report Number
    2242445-2011-00093
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 29, 2011
    Report Date
    July 12, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    FOZ
    PMA / PMN Number
    K071538
    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). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS BEING INSERTED INTO A MALE PT'S RIGHT INTERNAL JUGULAR IN THE INTENSIVE CARE UNIT. THE PHYSICIAN INSERTED THE DILATOR AS NORMAL. WHEN HE REMOVED THE DILATOR, A SMALL PORTION OF THE DISTAL TIP HAD FRACTURED OFF. THE PHYSICIAN NOTED HE DID NOT HIT THE CLAVICLE OR APPLY ANY MORE FORCE THAN NORMAL TO THE DILATOR. THEY COULD NOT FIND THE PIECE OF THE DILATOR THAT "CHIPPED OFF" AND BELIEVE IT IS STILL IN THE PT. THERE WAS NO DELAY IN TREATMENT, NO PT DEATH AND NO PT COMPLICATIONS WERE REPORTED. THE PT OUTCOME WAS GOOD. THE PHYSICIAN STATED THAT OTHER PHYSICIAN'S COMMENTED THAT THE DILATOR IS NOT AS STIFF AS IT USED TO BE AND IS BENDING FREQUENTLY AT THE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 8IN ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTERNATIONAL INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK