BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIDURAL CATHETERIZATION KIT

    MDR report key: 1910630 · Received November 19, 2010

    Report

    Report Number
    1036844-2010-00353
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    November 4, 2010
    Report Date
    November 18, 2010
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    CAZ
    PMA / PMN Number
    K884552
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 ON NOVEMBER 2, THE CATHETER WAS INSERTED INTO THE LOWER BACK OF A FEMALE PT IN THE OPERATING ROOM. ON NOVEMBER 4 IN THE MEDICAL WARD, THE CATHETER BROKE OUTSIDE THE PT'S BODY WHEN IT WAS BEING REMOVED. THE MD TRIED TO REMOVE THE CATHETER AGAIN, BUT IT WAS BROKEN 7CM FROM THE CATHETER TIP AND REMAINED IN THE PT'S BODY. ON NOVEMBER 5, THE REMAINING PART OF THE CATHETER WAS SURGICALLY REMOVED WITH A 2CM CUT. THE MD FOUND THAT THE CATHETER TIP HAD COME OUT OF THE EPIDURAL SPACE AND STUCK UNDER THE SKIN (MUSCLE TISSUE). ONLY 2 CATHETER PIECES (THE CATHETER WAS BROKEN INTO 3 PARTS) ARE BEING RETURNED. THE HOSPITAL DISCARDED THE MIDDLE PART OF THE CATHETER. THE PT WAS DISCHARGED FROM THE HOSPITAL ON NOVEMBER 9 IN GOOD CONDITION. THERE WAS NO DEATH OR COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIDURAL CATHETERIZATION KIT ANESTHESIA PRODUCTS CAZ ARROW INTERNATIONAL INC RF0061673

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention