BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVOL® FEMALE CATH KIT

    MDR report key: 16584468 · Received March 21, 2023

    Report

    Report Number
    1018233-2023-01922
    Event Type
    Malfunction
    Date Received
    March 21, 2023
    Date of Event
    October 26, 2022
    Report Date
    May 18, 2023
    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
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE "INLET PORT OF THE CAP / CATHETER (FR.) THICKNESS OUT OF SPECIFICATION". 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: "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." H11: SECTION A THROUGH F - 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. H3 OTHER TEXT: THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CATHETER IN THE FEMALE STRAIGHT CATHETER KIT WAS VERY LOOSE INSIDE OF CAP. CATHETER USED TO BE HELD IN PLACE INSIDE CAP WHICH WOULD ALLOW IT TO BE PULLED FORWARD BUT WOULD PREVENT IT FROM SLIDING BACK IN TUBE OR FALLING OUT. STATED THAT THE DANGER WAS THAT THE CATHETER COULD BE ADVANCED TO FAR FORWARD INTO THE URETHRA AND BECOME DIFFICULT TO REMOVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT CATHETER IN THE FEMALE STRAIGHT CATHETER KIT WAS VERY LOOSE INSIDE OF CAP. CATHETER USED TO BE HELD IN PLACE INSIDE CAP WHICH WOULD ALLOW IT TO BE PULLED FORWARD BUT WOULD PREVENT IT FROM SLIDING BACK IN TUBE OR FALLING OUT. STATED THAT THE DANGER WAS THAT THE CATHETER COULD BE ADVANCED TO FAR FORWARD INTO THE URETHRA AND BECOME DIFFICULT TO REMOVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24216 DAVOL® FEMALE CATH KIT FEMALE CATHETER KIT FFH C.R. BARD, INC. (COVINGTON) -1018233 0035380 NGGS1335 00801741045820

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other