BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DAVOL® PEDIATRIC CATH KIT

    MDR report key: 17710359 · Received September 8, 2023

    Report

    Report Number
    1018233-2023-06668
    Event Type
    Malfunction
    Date Received
    September 8, 2023
    Date of Event
    August 18, 2023
    Report Date
    November 21, 2023
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    FFH
    UDI-DI
    00801741045851
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS CONFIRMED CAUSE UNKNOWN. 1SAMPLE WERE CONFIRMED TO EXHIBIT THE REPORTED FAILURE. THE DEVICE HAD NOT MET SPECIFICATIONS. VISUAL EVALUATION OF THE RETURNED SAMPLE NOTED ONE OPENED (WITHOUT ORIGINAL PACKAGING), PEDIATRIC CATHETER IN CENTRIFUGE TUBE WITH LUBRICANT. VISUAL INSPECTION OF THE SAMPLE NOTED STERILE CONTAINER FELL OFF CATHETER EASILY ALSO, LUBE PERFORATIONS ON THE PACKING DIFFICULT TO OPEN. A POTENTIAL ROOT CAUSE FOR THIS FAILURE MODE COULD BE ¿INCORRECT LINE CLEARANCE". 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: "SINGLE USE. DO NOT RESTERILIZE. DO NOT USE IF PACKAGE IS DAMAGED. NOT MADE WITH NATURAL RUBBER LATEX. INSTRUCTIONS FOR USE: 1. OPEN PACKAGE AND REMOVE PLASTIC WALLET. 2. OPEN PLASTIC WALLET. 3. PLACE INFANT IN SUPINE POSITION, THIGHS ABDUCTED. 4. CLEANSE THE AREA AROUND THE MEATUS WITH POVIDONE-IODINE SWABS. 5. PUT ON STERILE GLOVES. 6. PLACE THE TIP OF THE CATHETER IN STERILE LUBRICANT AND CATHETERIZE PATIENT. 7. AFTER URINE IS COLLECTED, PULL CATHETER OUT OF CAP. 8. TIGHTEN CAP AND DEPRESS SPOUT. 9. LABEL CENTRIFUGE TUBE. 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. 8 FR. CATHETER IN CENTRIFUGE TUBE ¿ POVIDONE-IODINE SWABS ¿ VINYL GLOVES ¿ 3 GM LUBRICANT ¿ TOWEL ¿ LABEL" 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. H3 OTHER TEXT : THE ACTUAL/SUSPECTED DEVICE WAS INSPECTED.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NURSE WAS USING 8 FRENCH PEDIATRIC CATHETER KIT ON A 10 MONTH OLD BABY IN ORDER TO RULE OUT URINARY TRACT INFECTION. STERILE CONTAINER FELL OFF CATHETER ON ITS OWN DURING PROCEDURE. ALSO, LUBE WAS NEEDED SCISSORS TO BE OPENED BECAUSE THE PERFORATIONS ON LUBE WOULD NOT LET IT OPEN. THIS CAUSED URINE TO NOT TO BE COLLECTED AND INTERVENTION WAS NEEDED. THIS CAUSED A URINE BAG TO BE PLACED, BUT IF THE URINE COLLECTED FROM BAG HAS AN ABNORMAL DIPSTICK RESULT, ANOTHER CATHETER WOULD BE NEEDED TO BE PERFORMED. ANOTHER CATHETER KIT WITH THE SAME LOT NUMBER WAS OPENED AND HAD THE SAME MALFUNCTIONS AS THE KIT USED ON THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NURSE WAS USING 8 FRENCH PEDIATRIC CATHETER KIT ON A 10 MONTH OLD BABY IN ORDER TO RULE OUT URINARY TRACT INFECTION. STERILE CONTAINER FELL OFF CATHETER ON ITS OWN DURING PROCEDURE. ALSO, LUBE WAS NEEDED SCISSORS TO BE OPENED BECAUSE THE PERFORATIONS ON LUBE WOULD NOT LET IT OPEN. THIS CAUSED URINE TO NOT TO BE COLLECTED AND INTERVENTION WAS NEEDED. THIS CAUSED A URINE BAG TO BE PLACED, BUT IF THE URINE COLLECTED FROM BAG HAS AN ABNORMAL DIPSTICK RESULT, ANOTHER CATHETER WOULD BE NEEDED TO BE PERFORMED. ANOTHER CATHETER KIT WITH THE SAME LOT NUMBER WAS OPENED AND HAD THE SAME MALFUNCTIONS AS THE KIT USED ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663918 DAVOL® PEDIATRIC CATH KIT PEDIATRIC CATH KIT FFH C.R. BARD, INC. (COVINGTON) -1018233 NGGW4673 00801741045851

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other