BEUDAMED
    FDA Adverse Event Injury Summary report: N

    URINARY DRAINAGE BAGS - 2,0 L FF. 110CM 4OPH 25

    MDR report key: 3223739 · Received July 10, 2013

    Report

    Report Number
    3005778470-2013-00028
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 12, 2013
    Manufacturer
    CONVATEC
    Product Code
    KOD
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PT COMPLAINED ABOUT BELLY PAIN. URINE BAG CONTAINED 500ML URINE. A BLADDER SCAN WAS PERFORMED AND INDICATED THAT THE BLADDER HELD ABOUT 1000ML. THE NURSE DISCONNECTED THE CATHETER FROM THE URINE BAG AND 1000ML WAS DRAINED FROM THE BLADDER. UNFORTUNATELY, THE BAG WAS THROWN IN THE WASTE. PT IS DOING FINE. THIS IS DEEMED A SERIOUS INJURY AS IT REQUIRED A SCAN PROCEDURE AND A PROMPT INTERVENTION TO PREVENT A MORE SERIOUS CONSEQUENCE FOR THE PT (DISCONNECTION OF THE CATHETER FROM THE URINE BAG AND CONNECTION TO ANOTHER BAG TO GET THE URINE FLOWING AGAIN FROM THE BLADDER). NO NONCONFORMITY WAS REGISTERED DURING THE MANUFACTURING PROCESS. NO EARLIER COMPLAINTS WERE RECEIVED FOR THIS BATCH. NO SAMPLE WAS RETURNED FOR EVAL. REPORTED TO THE FDA ON (B)(4) 2013.

    Description of Event or Problem · 1

    URINE RETENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317871 URINARY DRAINAGE BAGS - 2,0 L FF. 110CM 4OPH 25 COLLECTOR, URINE (AND ACCESSORIES) FOR KOD CONVATEC 37 452 0 -10 462890

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention