BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URINARY DRAINAGE BAG

    MDR report key: 5996260 · Received October 4, 2016

    Report

    Report Number
    1018233-2016-01328
    Event Type
    Malfunction
    Date Received
    October 4, 2016
    Report Date
    October 26, 2016
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590
    Product Code
    KNX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Additional Manufacturer Narrative · 1

    RECEIVED 1 USED DRAINAGE BAG WITH THE CATHETER STILL ATTACHED. THE VISUAL INSPECTION NOTED NO OBVIOUS DEFECTS. THE RECEIVED SAMPLE WAS FUNCTIONALLY TESTED BY PASSING WATER THROUGH AN IN HOUSE 16FR. CATHETER (NOT PART OF THE SAMPLES RECEIVED). NO DRAINAGE PROBLEMS WERE OBSERVED; THE FLOW WAS CONTINUOUS DURING THE TEST ON THE SAMPLE RECEIVED. THE DRAINAGE TEST FOR CUSTOMER COMPLAINT-CATHETERS/DRAINAGE BAGS INDICATES THAT 250CC MUST BE DRAINED IN 64 SECONDS MAXIMUM. THE RESULTS FOR THE RECEIVED SAMPLE WERE THE FOLLOWING: TIME TO DRAIN 250CC: 39 SEC. THE SAMPLE RECEIVED REACHED THE INTENDED DRAINAGE INDICATED IN LESS THAN 64 SECONDS. THE REPORTED ISSUE COULD NOT BE CONFIRMED AS THE PROBLEM COULD NOT BE REPRODUCED. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE STATES THE FOLLOWING: "- VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. IF PACKAGE IS OPENED OR IF ANY IMPERFECTION OR SURFACE DETERIORATION IS OBSERVED, DO NOT USE. - PERIODIC OBSERVATIONS OF THIS SYSTEM SHOULD BE MADE TO ENSURE THAT URINE IS FLOWING FREELY. IF A STANDING COLUMN OF URINE IS OBSERVED, CHECK FOR CORRECT POSITIONING OF BAG AND THEN FOR A PHYSICAL OBSTRUCTION. IF CORRECT POSITIONING OR REMOVAL OF PHYSICAL OBSTRUCTION DOES NOT ALLOW FREE FLOW, THE BAG MAY HAVE TO BE CHANGED." (B)(4). THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRODUCT DID NOT DRAIN PROPERLY AND NEEDED TO BE "BURPED" SEVERAL TIMES IN ORDER TO DRAIN. AS A RESULT, THE PRODUCT WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRODUCT DID NOT DRAIN PROPERLY AND NEEDED TO BE "BURPED" SEVERAL TIMES IN ORDER TO DRAIN. AS A RESULT, THE PRODUCT WAS REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRODUCT DID NOT DRAIN PROPERLY AND NEEDED TO BE "BURPED" SEVERAL TIMES IN ORDER TO DRAIN. AS A RESULT, THE PRODUCT WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649707 URINARY DRAINAGE BAG URINE COLLECTION BAG KNX PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1