BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD® URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER

    MDR report key: 20724298 · Received November 19, 2024

    Report

    Report Number
    1018233-2024-07316
    Event Type
    Malfunction
    Date Received
    November 19, 2024
    Date of Event
    October 29, 2024
    Report Date
    January 8, 2025
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KNX
    UDI-DI
    00801741029509
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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. NO ACTIONS TAKEN AT THIS TIME SINCE A ROOT CAUSE WAS NOT IDENTIFIED. THE DHR REVIEW COULD NOT BE PERFORMED WITHOUT A LOT NUMBER. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: ¿INDICATIONS FOR USE: THE URINE DRAINAGE BAGS AND URINE METERS ARE INDICATED FOR URINE COLLECTION FOR PATIENTS REQUIRING URINARY CATHETERIZATION. INTENDED USE: FOR UROLOGICAL USE ONLY. CONTRAINDICATIONS: NO KNOWN CONTRAINDICATIONS. WARNINGS: AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH ACCEPTABLE MEDICAL PRACTICES AND APPLICABLE LOCAL, STATE AND FEDERAL LAWS AND REGULATIONS. THIS IS A SINGLE USE DEVICE. DO NOT RESTERILIZE ANY PORTION OF THIS DEVICE. REUSE AND/OR REPACKAGING MAY CREATE A RISK OF PATIENT OR USER INFECTION, COMPROMISE THE STRUCTURAL INTEGRITY AND/OR ESSENTIAL MATERIAL AND DESIGN CHARACTERISTICS OF THE DEVICE, WHICH MAY LEAD TO DEVICE FAILURE, AND/OR LEAD TO INJURY, ILLNESS OR DEATH OF THE PATIENT. USERS AND/OR PATIENTS WITHIN THE EUROPEAN UNION, SHOULD REPORT ANY SERIOUS INCIDENT THAT HAS OCCURRED IN RELATION TO THE DEVICE TO THE MANUFACTURER AND THE COMPETENT AUTHORITY OF THE MEMBER STATE IN WHICH THE USER AND/OR PATIENT IS ESTABLISHED. USERS OUTSIDE OF THE EUROPEAN UNION SHOULD REPORT ANY SERIOUS INCIDENT THAT HAS OCCURRED IN RELATION TO THE DEVICE TO THE MANUFACTURER AND THE REGULATORY AUTHORITY OF THE COUNTRY IN WHICH THE USER AND/OR PATIENT IS ESTABLISHED. CAUTIONS: FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A LICENSED HEALTHCARE PRACTITIONER. CONTAINS OR PRESENCE OF PHTHALATES: DI(2-ETHYLHEXYL) PHTHALATE (DEHP) IS A PLASTICIZER USED IN SOME POLYVINYL CHLORIDE MEDICAL DEVICES. DEHP HAS BEEN SHOWN TO PRODUCE A RANGE OF ADVERSE EFFECTS IN EXPERIMENTAL ANIMALS, NOTABLY LIVER TOXICITY, AND TESTICULAR ATROPHY. ALTHOUGH THE TOXIC AND CARCINOGENIC EFFECTS OF DEHP HAVE BEEN WELL ESTABLISHED IN EXPERIMENTAL ANIMALS, THE ABILITY OF THIS COMPOUND TO PRODUCE ADVERSE EFFECTS IN HUMANS IS CONTROVERSIAL. THERE IS NO EVIDENCE THAT NEONATES, INFANTS, PREGNANT AND BREAST-FEEDING WOMEN EXPOSED TO DEHP EXPERIENCE ANY RELATED ADVERSE EFFECTS. HOWEVER, A LACK OF EVIDENCE OF CAUSATION BETWEEN DEHP-PVC AND ANY DISEASE OR ADVERSE EFFECT DOES NOT MEAN THAT THERE IS NO RISK. PRECAUTION: DO NOT USE DEVICE IF PACKAGE IS OPENED OR DAMAGED. INSTRUCTIONS FOR USE: VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. IF PACKAGE IS OPENED OR IF ANY IMPERFECTION OR SURFACE DETERIORATION IS OBSERVED, DO NOT USE. 1. REMOVE PROTECTIVE CAP FROM DRAINAGE TUBE CATHETER ADAPTER AND CONNECT DRAINAGE TUBE TO CATHETER. 2. POSITION HANGER ON BEDSIDE RAIL, USING STRING OR HOOK. 3. USE SHEETING CLIP TO SECURE DRAINAGE TUBE TO SHEET. A. HANG DRAINAGE TUBE IN A STRAIGHT FASHION FROM BEDSIDE TO DRAINAGE BAG. ENSURE THAT THE DRAINAGE BAG IS PLACED NEAR THE FOOT OF THE BED. 4. IF USING A URINE METER, IT MAY BE EMPTIED IN TWO WAYS: A. TO EMPTY INTO THE BAG, GRASP THE BOTTOM OF THE METER AND LIFT UP. TO ENSURE THAT THE METER EMPTIES COMPLETELY, LIFTING AGAIN IS RECOMMENDED. B. TO EMPTY URINE METER INTO RECEPTACLE, TWIST GREEN PORTION OF DRAIN VALVE TO THE LEFT; TO CLOSE, TWIST GREEN POSITION OF THE DRAIN VALVE TO THE RIGHT. 5. TO EMPTY BAG: A. REMOVE OUTLET TUBE FROM HOUSING; GENTLY SQUEEZE CONNECTOR ARMS AND PULL TUBE FROM HOUSING. B. RELEASE CLAMP AND EMPTY BAG. C. AFTER EMPTYING, RECLAMP OUTLET TUBE AND SLIDE CONNECTOR INTO HOUSING UNTIL CONNECTOR ARMS ENGAGE. D. IF SPECIMEN IS REQUIRED, SEE INSTRUCTIONS FOR USING URINE SAMPLING PORT. 6. PERIODIC OBSERVATIONS OF THIS SYSTEM SHOULD BE MADE TO ENSURE THAT URINE IS FLOWING FREELY. IF A STANDING COLUMN OF URINE IS OBSERVED, CHECK FOR CORRECT POSITIONING OF BAG AND THEN FOR A PHYSICAL OBSTRUCTION. IF CORRECT POSITIONING OR REMOVAL OF PHYSICAL OBSTRUCTION DOES NOT ALLOW FREE FLOW, THE BAG MAY HAVE TO BE CHANGED. A. IF BAG IS NOT POSITIONED CORRECTLY, URINE MAY BYPASS THE METER AND GO DIRECTLY TO THE BAG. REPOSITION BAG, AS NECESSARY.¿ 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.

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. 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 NEW DRAIN BAGS DID NOT DRAIN COMPLETELY, WHEN DRAINING MAKING IT DIFFICULT TO CLEAN OUT BAG.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEW DRAIN BAGS DID NOT DRAIN COMPLETELY WHEN DRAINING AND MAKING IT DIFFICULT TO CLEAN OUT BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    43189 BARD® URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER DRAINAGE BAG KNX C.R. BARD, INC. (COVINGTON) -1018233 UNK 00801741029509

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other