BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEG BAG WITH FLIP-FLO VALVE, NO STRAPS, 19 OZ., STERILE

    MDR report key: 19982404 · Received August 14, 2024

    Report

    Report Number
    1018233-2024-04936
    Event Type
    Malfunction
    Date Received
    August 14, 2024
    Date of Event
    July 24, 2024
    Report Date
    August 28, 2024
    Manufacturer
    C.R. BARD INC. (COVINGTON) -1018233
    Product Code
    FAQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. THIS REPORT REFERENCES A US EQUIVALENT DEVICE. THE US UDI EQUIVALENT FOR THIS PRODUCT NUMBER IS USED. 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. 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 TUBING DOES NOT MEET SPECIFICATION. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: WARNING: DO NOT USE OINTMENTS OR LUBRICANTS HAVING A PETROLATUM BASE. THEY WILL DAMAGE THE CATHETER. VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE. USE LUER TIP SYRINGE TO INFLATE WITH STATED ML OF STERILE WATER. OR FOR PRE-FILLED PRODUCTS, REMOVE CLIP AND SQUEEZE RESERVOIR TO INFLATE WITH STATED ML OF STERILE WATER. FOR UROLOGICAL USE ONLY. BARD, BARDIA, BARDEX, URIPLAN, EZ-LOK, AND LUBRICATH ARE TRADEMARKS AND/OR REGISTERED TRADEMARKS OF C. R. BARD, INC. MANUFACTURER: VALVE TYPE: USE LUER SLIP TIP SYRINGE. DO NOT USE NEEDLE. RECOMMENDED INFLATION CAPACITIES: 3CC BALLOON: USE 5ML STERILE WATER; 5CC BALLOON: USE 10ML STERILE WATER; 15CC BALLOON: USE 20ML STERILE WATER; 20CC BALLOON: USE 25ML STERILE WATER; 30CC BALLOON: USE 35ML STERILE WATER; 40CC BALLOON: USE 45ML STERILE WATER; 75CC BALLOON: USE 80ML STERILE WATER. DO NOT EXCEED RECOMMENDED CAPACITIES. TO DEFLATE CATHETER BALLOON: GENTLY INSERT A LUER SLIP TIP SYRINGE IN THE CATHETER VALVE. NEVER USE MORE FORCE THAN IS REQUIRED TO MAKE THE SYRINGE STICK IN THE VALVE. ALLOW THE PRESSURE WITHIN THE BALLOON TO FORCE THE PLUNGER BACK AND FILL THE SYRINGE WITH WATER. IF YOU NOTICE SLOW OR NO DEFLATION, RE-SEAT THE SYRINGE GENTLY. USE ONLY GENTLE ASPIRATION TO ENCOURAGE DEFLATION IF NEEDED. VIGOROUS ASPIRATION MAY COLLAPSE THE INFLATION LUMEN, PREVENTING BALLOON DEFLATION. IF NECESSARY, CONTACT ADEQUATELY TRAINED PROFESSIONAL FOR ASSISTANCE, AS DIRECTED BY HOSPITAL PROTOCOL. SHOULD BALLOON RUPTURE OCCUR, CARE SHOULD BE TAKEN TO ASSURE THAT ALL BALLOON FRAGMENTS HAVE BEEN REMOVED FROM THE PATIENT. A NEW CONNECTOR WITH A NEEDLE FREE SAMPLE PORT HAS BEEN ADDED TO THIS PRODUCT. INSTRUCTIONS FOR USE FOR THE NEEDLE-FREE SAMPLING KINK THE DRAINAGE TUBING AT A MINIMUM OF 5CM BELOW THE SAMPLING PORT. WIPE THE SURFACE OF THE PORT WITH AN ALCOHOL SWAB. USING AN ASEPTIC TECHNIQUE, POSITION THE SYRINGE (LUER SLIP TIP ONLY) IN THE CENTRE, PERPENDICULAR TO THE SURFACE OF THE PORT, AND THEN PRESS THE TIP OF THE SYRINGE INTO THE SAMPLING PORT. ASPIRATE THE DESIRED VOLUME AND THEN REMOVE THE SYRINGE. WIPE THE SURFACE OF THE PORT WITH AN ALCOHOL SWAB. UNKINK THE TUBING AND SEND THE CORRECTLY LABELLED SPECIMEN TO THE LABORATORY. 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 NIGHT BAG TUBE OF D813131 KINKS AND MEANS THAT NO URINE CAN GO THROUGH, HAD HAPPENED TO 3 OF THEM. NO MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NIGHT BAG TUBE OF D813131 KINKS AND MEANS THAT NO URINE CAN GO THROUGH, HAD HAPPENED TO 3 OF THEM. NO MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535084 LEG BAG WITH FLIP-FLO VALVE, NO STRAPS, 19 OZ., STERILE URIPLAN BED BAG FAQ C.R. BARD INC. (COVINGTON) -1018233 NGHZ3186

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other