BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVOL® FEMALE CATH KIT

    MDR report key: 19498671 · Received June 10, 2024

    Report

    Report Number
    1018233-2024-03388
    Event Type
    Malfunction
    Date Received
    June 10, 2024
    Date of Event
    May 20, 2024
    Report Date
    September 10, 2024
    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
    OTHER HEALTH CARE PROFESSIONAL
    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. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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 BD.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS AVAILABLE FOR EVALUATION AND FURTHER INVESTIGATION DID NOT RESULT IN ANY ADDITIONAL FINDINGS. THE EXACT ROOT CAUSE COULD NOT BE IDENTIFIED. ALTHOUGH A ROOT CAUSE COULD NOT BE DEFINITIVELY IDENTIFIED, BASED ON THE RISK DOCUMENTATION REVIEW, A POTENTIAL ROOT CAUSE FOR THIS TYPE OF FAILURE COULD BE COMPONENTS DAMAGE: RECEIVED FROM SUPPLIER. HOWEVER, THERE WAS INSUFFICIENT INFORMATION TO CONFIRM THIS POTENTIAL ROOT CAUSE. THE DHR REVIEW COULD NOT BE PERFORMED WITHOUT A LOT NUMBER. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND 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. IF URINE DOES NOT FLOW FREELY INTO THE TUBE, THE CAP MAY NEED TO BE LOOSENED SLIGHTLY. CONTENTS: 8 FR. CATHETER IN CENTRIFUGE TUBE: POVIDONE-IODINE SWABS; VINYL GLOVES; LABEL. 3 GM LUBRICANT: STERILIZED BY ETHYLENE OXIDE; SINGLE USE.; DO NOT RESTERILIZE. DO NOT USE IF PACKAGE IS DAMAGED. NOT MADE WITH NATURAL RUBBER LATEX. CAUTION: FEDERAL (U.S.A.) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. UDI FORMAT UPDATED WITH AVAILABLE PRODUCT INFORMATION PER GUDID. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL 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 BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CATHETER TUBE IN THE FEMALE STRAIGHT CATHETER KIT SNAPPED IN HALF WHEN TRYING TO PULL THE CATHETER FURTHER OUT OF THE COLLECTION TUBE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CATHETER TUBE IN THE FEMALE STRAIGHT CATHETER KIT SNAPPED IN HALF WHEN TRYING TO PULL THE CATHETER FURTHER OUT OF THE COLLECTION TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608462 DAVOL® FEMALE CATH KIT FEMALE CATHETER KIT FFH C.R. BARD, INC. (COVINGTON) -1018233 UNK 00801741045820

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other