BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVOL® FEMALE CATH KIT

    MDR report key: 6988615 · Received October 30, 2017

    Report

    Report Number
    1018233-2017-05571
    Event Type
    Malfunction
    Date Received
    October 30, 2017
    Report Date
    February 12, 2018
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    FFH
    UDI-DI
    00801741045820
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS UNCONFIRMED. RECEIVED 1 UNOPENED FEMALE CATHETER KIT FOR EVALUATION. DURING THE VISUAL INSPECTION NO OBVIOUS DEFECTS WERE NOTICED IN THE SAMPLE. IN ORDER TO VERIFY THE REPORTED ISSUE. PER FUNCTIONAL ASSESSMENT, THE SAMPLE WAS FOUND ACCEPTABLE SINCE WATER FLOWED THROUGH THE CATHETER WITHOUT ANY DIFFICULTY.THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING: "FEMALE CATH KIT WITH GLOVES AND SWABS INSTRUCTIONS FOR USE: 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 IN 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." (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CATHETER WAS NOT DRAINING URINE AFTER INSERTION IN THE CORRECT ANATOMICAL PLACEMENT. IT WAS NOTED THAT ANOTHER CATHETER WAS INSERTED AND DRAINED SUCCESSFULLY.

    Additional Manufacturer Narrative · 1

    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 STATE THE FOLLOWING: "FEMALE CATH KIT WITH GLOVES AND SWABS. INSTRUCTIONS FOR USE: OPEN PACKAGE AND REMOVE PLASTIC WALLET. OPEN PLASTIC WALLET AND DON GLOVES. PULL CATHETER OUT OF TUBE TO DESIRED LENGTH. LAY TUBE IN STERILE FIELD. OPEN LUBRICANT AND LUBRICATE CATHETER. OPEN SWAB PACKET. CLEANSE VAGINAL AREA. PROCEED WITH CATHETERIZATION. PULL CATHETER OUT OF TOP; TIGHTEN COVER AND DEPRESS BLUE SPOUT. FILL OUT LABEL, PLACE ON CENTRIFUGE TUBE. SEND TO LAB IN NORMAL MANNER. IMPORTANT: USE PLASTIC WALLET AS STERILE FIELD. 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." (B)(4). THE DEVICE WAS NOT RETURNED.

    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. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS NOT DRAINING URINE AFTER INSERTION IN THE CORRECT ANATOMICAL PLACEMENT. IT WAS NOTED THAT ANOTHER CATHETER WAS INSERTED AND DRAINED SUCCESSFULLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS NOT DRAINING URINE AFTER INSERTION IN THE CORRECT ANATOMICAL PLACEMENT. IT WAS NOTED THAT ANOTHER CATHETER WAS INSERTED AND DRAINED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765894 DAVOL® FEMALE CATH KIT FEMALE CATH KIT FFH C.R. BARD, INC. (COVINGTON) -1018233 NGBS0871 00801741045820

    Patients

    Seq Age Sex Outcome Treatment
    1