BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD 350ML URINE METER DRAIN BAG

    MDR report key: 2230796 · Received August 23, 2011

    Report

    Report Number
    1018233-2011-00198
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 26, 2011
    Manufacturer
    C.R. BARD, INC.
    Product Code
    EXR
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION. HOWEVER, PHOTOGRAPHIC IMAGES WERE SENT IN LIEU OF THE ACTUAL DEVICE. VISUAL INSPECTION OF THE DEVICE IN THE PHOTOS DID NOT REVEAL ANY ANOMALIES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE DIMENSIONAL VALUES COULD NOT BE ASSESSED W/O THE ACTUAL SAMPLE. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. THE GUIDELINES FOR DRAINAGE FOR THE BARD URINARY SYSTEM STATES, "URINARY DRAINAGE BAG SHOULD BE PLACED NEAR THE FOOT OF THE BED, AND BELOW THE LEVEL OF THE PATIENT'S HIP." BASED UPON THE REPORTED EVENT AND VISUAL INSPECTION OF THE PHOTOS, THE DEVICE WAS HUNG ON THE BED'S MOVABLE SIDERAIL AND THE SIDERAIL WAS UP DURING THE INCIDENT. THERE WAS NO PROBLEM WITH THE DEVICE. THE EVENT OCCURRED AS A RESULT OF THE PATIENT MOVING HER LEG OVER THE BEDRAIL WHERE THE BAG WAS HANGING. THE DRAINAGE BAG WAS NOT HUNG NEAR THE FOOT OF THE BED AND BELOW THE LEVEL OF THE PATIENT'S HIP ACCORDING TO THE GUIDELINES FOR DRAINAGE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT MOVED HER LEG OVER THE BED RAIL TO SIT UP, HER LEG GOT CAUGHT ON THE BAG HOOK CAUSING A 5CM TRIANGULAR SKIN TEAR ON THE CALF PORTION OF HER LEG. THE PATIENT REQUIRED SUTURES TO CLOSE THE SKIN TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD 350ML URINE METER DRAIN BAG EXR C.R. BARD, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention