BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIDURAL CATHETERIZATION KIT

    MDR report key: 1971513 · Received January 21, 2011

    Report

    Report Number
    1036844-2011-00031
    Event Type
    Injury
    Date Received
    January 21, 2011
    Date of Event
    December 10, 2010
    Report Date
    January 20, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    CAZ
    PMA / PMN Number
    K770461
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE CATHETER WAS BEING REMOVED FROM THE (B)(6) OLD MALE PT'S L2 IN ORTHOPEDICS, A DAY AFTER IT WAS INSERTED IN THE OPERATING ROOM, RESISTANCE WAS ENCOUNTERED WHICH RESULTED IN THE CATHETER SEPARATING. AS A RESULT, A SMALL INCISION WAS MADE TO REMOVE THE CATHETER REMAINING IN THE BODY. IT WAS NOT REPLACED BECAUSE THE PT DID NOT NEED FURTHER PAIN CONTROL. THE PT WAS IN FLEXED POSITION WHEN THE CATHETER WAS INSERTED AND REMOVED. THERE WAS NO DELAY, DEATH OR COMPLICATIONS TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIDURAL CATHETERIZATION KIT ANESTHESIA PRODUCTS CAZ ARROW INTL., INC. RF0050597

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention