BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILIC FOLEY CATH 5/10ML /5

    MDR report key: 8345835 · Received February 15, 2019

    Report

    Report Number
    9610711-2019-00005
    Event Type
    Injury
    Date Received
    February 15, 2019
    Date of Event
    January 12, 2019
    Report Date
    February 13, 2019
    Manufacturer
    COLOPLAST A/S
    Product Code
    EZL
    UDI-DI
    03600040127360
    PMA / PMN Number
    K013174
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER RECEIVING THIS COMPLAINT, WE SEARCHED FOR OTHER COMPLAINT AND WE DIDN'T FIND OTHER COMPLAINT ON THIS LOT. CHECKING THE QUALITY DATABASES REVEALED NO ANOMALY IN CONNECTION WITH THE DESCRIBED DEFECT. ON JANUARY 25 WE RECEIVED 1 USED SAMPLE WITH A GREEN VALVE N° LOT 6202641 AND DECONTAMINATED IT WITH ANIOXYDE 1000- THE BALLOON WAS INFLATED WITH 10 ML OF OSMOSIS WATER. A FLOW TEST WAS PERFORMED WITH THE WATER COLUMN AT 1 METER AND THE RESULT WAS 403.55ML/MN AND CONFORM. AFTER THAT, WE PUT THE CATHETER INSIDE A SIMULATION BATH FROM JANUARY 30 UNTIL FEBRUARY 13 - THE DEVICE WAS INFLATED WITH 10ML OF OSMOSIS WATER - THE RESULT OF THE TEST SHOWS NO ANOMALY. IT IS CONCLUDED THAT THE RISKS IDENTIFIED ARE STILL ACCEPTABLE AND CONSIDERED AS SAFE. BASED ON THE ABOVE, THIS COMPLAINT IS NOT CONFIRMED AS A PRODUCT DEFECT.

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION, THE CATHETER WAS INSERTED IN A PREGNANT WOMAN. THERE WAS PRESENCE OF URINE IN THE COLLECTING BAG. PASSAGE AT THE SURGICAL ROOM FOR CAESAREAN. AS SOON AS THE INCISION IS MADE, THE GYNECOLOGIST FINDS THAT THE PATIENT HAS A URINARY GLOBE WITH ABOUT 500 ML OF URINE. UNSUCCESSFUL ATTEMPT TO MAKE THE CATHETER WORK. NEW CATHETER WAS INSERTED, IN THE MEAN TIME, DESCENT OF THE BABY NATURALLY. CAESAREAN SECTION COULD HAVE BEEN AVOIDED IF THE CATHETER HAD FUNCTIONED NORMALLY. CONSEQUENCE: CAESAREAN SECTION DUE TO DYSFUNCTION OF THE URINARY CATHETER. EXTENSION OF THE DURATION OF CAESAREAN. ADDITIONAL INFORMATION WAS RECEIVED FROM THE HOSPITAL BY COLOPLAST: BLADDER CATHETERIZATION: CONDITIONS OF REALIZATION: INDWELLING CATHETERIZATION AT THE BED OF THE PATIENT IN THE DELIVERY ROOM AT 02:00. POSSIBLE DIFFICULTY ENCOUNTERED? NOT REPORTED. POSITION OF THE HEAD AT THE TIME OF THE SURVEY? DORSAL DECUBITUS, INCLINATION 30 °. AMOUNT OF URINE COLLECTED? NOT REPORTED. CESAREAN: INDICATION OF CAESAREAN ? STAGNATION OF THE DILATATION TO 4CM. WHERE IS THE PRESENTATION IN THE POOL? FIXED CEPHALIC PRESENTATION. TIME BETWEEN CATHETERIZATION AND CAESAREAN? 8H. IS THE SAME CATHETER IN PLACE FOR CAESAREAN OR HAS ANOTHER ONE BEEN PLACED? THE SAME CATHETER IS IN PLACE AT THE TIME OF INCISION. NEED TO CHANGE IT WHEN ACCESSING THE PERITONEAL CAVITY DUE TO A 500CC URINARY GLOBE. PERFUSION: AMOUNT OF FLUID INFUSED BETWEEN CATHETERIZATION AND CAESAREAN ? 1L. WHAT DO YOU ATTRIBUTE TO THE CATHETERIZATION PROBLEM? I DID NOT FIND ANY CAUSE THAT COULD EXPLAIN THE BLADDER GLOBE BECAUSE THE BLADDER CATHETER WAS IN PLACE EFFECTIVELY AND IT WAS OBVIOUSLY NOT CLOGGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136009 SILIC FOLEY CATH 5/10ML /5 SILICONE FOLEY CATHETER EZL COLOPLAST A/S AA61141002 06202641 03600040127360

    Patients

    Seq Age Sex Outcome Treatment
    1 Other