BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEXLUBRICATH FOLEY CATHETER ALCOCK MODEL

    MDR report key: 12035470 · Received June 21, 2021

    Report

    Report Number
    1018233-2021-03667
    Event Type
    Malfunction
    Date Received
    June 21, 2021
    Date of Event
    May 14, 2021
    Report Date
    October 19, 2021
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    KOD
    UDI-DI
    00801741018756
    PMA / PMN Number
    K922431
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS CONFIRMED MANUFACTURING RELATED. 1 SAMPLE WAS CONFIRMED TO EXHIBIT THE REPORTED FAILURE. THE DEVICE HAD NOT MET SPECIFICATIONS. THE PRODUCT WAS USED FOR TREATMENT. THE PRODUCT CAUSED THE REPORTED FAILURE. VISUAL EVALUATION OF THE RETURNED SAMPLE NOTED ONE OPENED (WITHOUT ORIGINAL PACKAGING), USED 3 WAY LATEX FOLEY CATHETER WAS RETURNED OPENED. VISUAL INSPECTION OF THE SAMPLE NOTED THAT THERE WAS A SHORT ROUNDED RIP NEAR THE BALLOON. AS THERE IS WHAT SEEMS TO BE BLUE SLEEVE MATERIAL IN THE RIP, THIS SHOULD BE CONSIDERED TO BE A BAGGER CUT. THIS DOES NOT MEET THE SPECIFICATION "COMPONENTS ARE TO BE PRESENT, CORRECT, UNDAMAGED, AND APPROVED BY Q. A. COMPONENTS ARE TO BE ASSEMBLED PER THE LATEST DRAWING." PER SECTION 6.1 OF 0134L18Y-26Y, REVISION 3. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE ¿OPERATOR ERROR¿. 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: "STERILE UNLESS PACKAGE IS OPENED OR DAMAGED. WARNING: ON CATHETER, DO NOT USE OINTMENTS OR LUBRICANTS HAVING PETROLATUM BASE. THEY WILL DAMAGE LATEX AND MAY CAUSE THE BALLOON TO BURST. CAUTION: DO NOT ASPIRATE URINE THROUGH DRAINAGE FUNNEL WALL. STORAGE: STORE CATHETERS AT ROOM TEMPERATURE AWAY FROM DIRECT EXPOSURE TO LIGHT, PREFERABLY IN THE ORIGINAL BOX. SINGLE PATIENT USE ONLY. DO NOT REUSE. DO NOT RESTERILIZE. FOR UROLOGICAL USE ONLY. 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 AND 75CC BALLOON: USE 80ML STERILE WATER. DO NOT EXCEED RECOMMENDED CAPACITIES. WARNING: AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH APPLICABLE LOCAL, STATE, AND FEDERAL LAWS AND REGULATIONS. 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 PERMITTED BY HOSPITAL PROTOCOL, THE VALVE ARM MAY BE SEVERED. IF THIS FAILS, 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. VISUALLY INSPECT THE PRODUCT FOR ANY IMPERFECTIONS OR SURFACE DETERIORATION PRIOR TO USE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A CUT FOUND ON THE CATHETER TIP UPON OPENING THE PACKAGE. STATED THAT THE DEVICE WAS NOT USED. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON (B)(6) 2021, IT WAS CONFIRMED THAT THERE WAS A TEAR ON THE CATHETER SHAFT NEAR THE BALLOON.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A CUT FOUND ON THE CATHETER TIP UPON OPENING THE PACKAGE. STATED THAT THE DEVICE WAS NOT USED. PER ADDITIONAL INFORMATION VIA EMAIL FROM IBC ON (B)(6) 2021, IT WAS CONFIRMED THAT THERE WAS A TEAR ON THE CATHETER SHAFT NEAR THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930974 BARDEXLUBRICATH FOLEY CATHETER ALCOCK MODEL FOLEY CATHETER KOD C.R. BARD, INC. (COVINGTON) -1018233 0134L18 NGEV2697 00801741018756

    Patients

    Seq Age Sex Outcome Treatment
    1 Other