BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINAL ANES/EPIDURAL CAT H KIT

    MDR report key: 2133910 · Received June 15, 2011

    Report

    Report Number
    1036844-2011-00194
    Event Type
    Malfunction
    Date Received
    June 15, 2011
    Date of Event
    May 9, 2011
    Report Date
    June 14, 2011
    Manufacturer
    ARROW INTL., 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). SAMPLE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED PER MEDWATCH REPORT THAT THE PROCEDURE WAS BEING PERFORMED ON A (B)(6) YEAR OLD FEMALE PT FOR A LEFT KNEE REPLACEMENT. AN EPIDURAL CATHETER WS INSERTED INTO THE PT PRE-OPERATIVELY BY THE PHYSICIAN. FOLLOWING SURGERY, THE CATHETER WAS PULLED BY THE NURSE AND UPON ASSESSMENT OF THE CATHETER, THE TIP OF THE CATHETER WAS NOTED TO BE MISSING. A CT SCAN WAS ORDERED TO DETERMINE WHERE THE TIP WAS LOCATED. THE CT SCAN REVEALED THAT THE TIP OF THE CATHETER WAS LOCATED IN THE EPIDURAL SPACE OF L3-L4. THE PT DECLINED SURGICAL INTERVENTION FOR REMOVAL OF THE CATHETER TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINAL ANES/EPIDURAL CAT H KIT ANESTHESIA PRODUCTS CAZ ARROW INTL., INC. RF1011553

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR