BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15417834 · Received September 14, 2022

    Report

    Report Number
    1018233-2022-07099
    Event Type
    Malfunction
    Date Received
    September 14, 2022
    Date of Event
    September 3, 2022
    Report Date
    December 30, 2022
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KNX
    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.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE DUE TO "TUBING DOES NOT MEET 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: "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: 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. 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. A NEW CONNECTOR WITH A NEEDLE FREE SAMPLE PORT HAS BEEN ADDED TO THIS PRODUCT. INSTRUCTIONS FOR USE FOR THE NEEDLE-FREE SAMPLING 1. KINK THE DRAINAGE TUBING AT A MINIMUM OF 5CM BELOW THE SAMPLING PORT. 2. WIPE THE SURFACE OF THE PORT WITH AN ALCOHOL SWAB. 3. 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. 4. ASPIRATE THE DESIRED VOLUME AND THEN REMOVE THE SYRINGE. 5. WIPE THE SURFACE OF THE PORT WITH AN ALCOHOL SWAB. 6. UNKINK THE TUBING AND SEND THE CORRECTLY LABELLED SPECIMEN TO THE LABORATORY." CORRECTION: H 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 THE NOZZLE ON THE BED BAG WAS DIFFICULT TO INSERT AND REMOVE . ONE OF THE NOZZLES CAME OFF FROM THE SHEATH ALTOGETHER CAUSING AN ACCIDENT . THE CUSTOMER STATED THAT THESE BED BAGS WERE NOT FLEXIBLE AS THE UNOMEDICAL BAGS, AND THESE BAGS KINKED A LOT MORE . IT WAS NOTED THAT THE CUSTOMER WAS USING BEG BAG MATERIAL# D813131 WITH HOLLISTER SHEATHS MATERIAL# 97225.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NOZZLE ON THE BED BAG WAS DIFFICULT TO INSERT AND REMOVE . ONE OF THE NOZZLES CAME OFF FROM THE SHEATH ALTOGETHER CAUSING AN ACCIDENT . THE CUSTOMER STATED THAT THESE BED BAGS WERE NOT FLEXIBLE AS THE UNOMEDICAL BAGS , AND THESE BAGS KINKED A LOT MORE . IT WAS NOTED THAT THE CUSTOMER WAS USING BEG BAG MATERIAL# D813131 WITH HOLLISTER SHEATHS MATERIAL# 97225.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2675058 LEG BAG WITH FLIP-FLO VALVE, NO STRAPS, 19 OZ., STERILE LEG BAG KNX C.R. BARD, INC. (COVINGTON) -1018233 NGGP1564

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other