BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DAVOL® FEMALE CATH KIT

    MDR report key: 8189522 · Received December 21, 2018

    Report

    Report Number
    1018233-2018-06109
    Event Type
    Injury
    Date Received
    December 21, 2018
    Report Date
    February 4, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    FFH
    UDI-DI
    00801741045837
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: ¿1. OPEN PACKAGE AND REMOVE PLASTIC WALLET. 2. OPEN PLASTIC WALLET AND DON GLOVES. 3. PULL CATHETER OUT OF TUBE TO DESIRED LENGTH. LAY TUBE ON STERILE FIELD. 4. OPEN LUBRICANT AND LUBRICATE CATHETER. 5. OPEN SWAB PACKET. CLEANSE VAGINAL AREA. 6. PROCEED WITH CATHETERIZATION. 7. PULL CATHETER OUT OF TOP; TIGHTEN COVER AND DEPRESS BLUE SPOUT. 8. FILL OUT LABEL, PLACE ON CENTRIFUGE TUBE. SEND TO LAB IN NORMAL MANNER. IMPORTANT: 1. USE PLASTIC WALLET AS STERILE FIELD. 2. PULL CATHETER OUT OF CENTRIFUGE TUBE TO THE PROPER LENGTH IMMEDIATELY AFTER DONNING GLOVES. NOTE: IF URINE DOES NOT FLOW FREELY INTO THE TUBE, THE CAP MAY NEED TO BE LOOSENED SLIGHTLY."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GLOVES INSIDE OF THE FEMALE CATHETER KIT WERE STICKING TO EACH OTHER, WHICH RESULTED IN ONE OF THE GLOVES FALLING OUT OF THE TRAY ONTO A NON-STERILE SURFACE. THE COMPLAINANT REPORTED THAT THE ISSUE COULD BE CONTRIBUTING TO CATHETER ASSOCIATED INFECTIONS. PER FOLLOW UP WITH THE COMPLAINANT BY PHONE ON DEC 12 2018 IT WAS NOTED THAT UTIS WERE DIAGNOSED BUT THERE WAS NO INFORMATION AVAILABLE ON THE SPECIFIC TREATMENT PROVIDED.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GLOVES INSIDE OF THE FEMALE CATHETER KIT WERE STICKING TO EACH OTHER, WHICH RESULTED IN ONE OF THE GLOVES FALLING OUT OF THE TRAY ONTO A NON-STERILE SURFACE. THE COMPLAINANT REPORTED THAT THE ISSUE COULD BE CONTRIBUTING TO CATHETER ASSOCIATED INFECTIONS. PER FOLLOW UP WITH THE COMPLAINANT BY PHONE ON (B)(6) 2018 IT WAS NOTED THAT UTIS WERE DIAGNOSED BUT THERE WAS NO INFORMATION AVAILABLE ON THE SPECIFIC TREATMENT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030668 DAVOL® FEMALE CATH KIT FEMALE CATHETER KIT FFH C.R. BARD, INC. (COVINGTON) -1018233 NGCU3528 00801741045837

    Patients

    Seq Age Sex Outcome Treatment
    1 Other