BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINAL ANES/EPIDURAL CAT H KIT

    MDR report key: 2922062 · Received January 15, 2013

    Report

    Report Number
    1036844-2013-00013
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    January 12, 2013
    Report Date
    January 15, 2013
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    CAZ
    PMA / PMN Number
    K884552
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 IN THE OPERATING ROOM, THE METAL TIP OF THE 10CC GLASS SYRINGE HAD BROKEN OFF. AS A RESULT, THEY GRABBED ANOTHER 10CC SYRINGE FROM THERE STOCK TO COMPLETE THE PROCEDURE. THERE WAS NOT DELAY IN TREATMENT. NO COMPLICATIONS OR DEATH OCCURRED TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22799 SPINAL ANES/EPIDURAL CAT H KIT ANESTHESIA PRODUCTS CAZ ARROW INTERNATIONAL INC. RM2097004

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK