BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER

    MDR report key: 9714179 · Received February 14, 2020

    Report

    Report Number
    1018233-2020-01071
    Event Type
    Malfunction
    Date Received
    February 14, 2020
    Date of Event
    December 8, 2019
    Report Date
    April 14, 2020
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EZL
    UDI-DI
    00801741034275
    PMA / PMN Number
    K984084
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. A POTENTIAL FAILURE MODE COULD BE ¿PINHOLE¿ WITH A POTENTIAL ROOT CAUSE OF "IMPERFECTION IN BALLOON DUE TO PROCESS". 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: ¿C.R. BARD, INC. COVINGTON, GA 30014 U.S.A. MADE IN MEXICO LUBRICIOUS COATING BONDED TO A BARDEX® FOLEY CATHETER MADE OF CLEAR SILICONE ELASTOMER PK7602585 04/2006 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. WARNING: ON CATHETER, DO NOT USE OINTMENTS OR LUBRICANTS HAVING PETROLATUM BASE. THEY WILL DAMAGE SILICONE AND MAY CAUSE THE BALLOON TO BURST. CAUTION: FEDERAL (U.S.A.) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. UNLESS PACKAGE IS OPENED OR DAMAGED. 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 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 5CC STERILE WATER 5CC BALLOON: USE 10CC STERILE WATER 30CC BALLOON: USE 35CC STERILE WATER DO NOT EXCEED RECOMMENDED CAPACITIES. NOTE: AGGRESSIVE TRACTION, PARTICULARLY IN THE PRESENCE OF SUTURING, IS NOT RECOMMENDED FOR SILICONE FOLEY CATHETERS. BARD, BARDEX AND LUBRI-SIL ARE REGISTERED TRADEMARKS OF C. R. BARD, INC. OR AN AFFILIATE. U.S. PATENT NUMBER 5,179,174 AND PATENT PENDING. 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. IF YOU NOTICE SLOW OR NO DEFLATION, RE-SEAT THE SYRINGE GENTLY. ALLOW THE BALLOON TO DEFLATE SLOWLY ON ITS OWN. DO NOT ASPIRATE OR MANUALLY ACCELERATE THE DEFLATION OF THE BALLOON. 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. LUBRI-SIL® ALL-SILICONE FOLEY CATHETER PEEL TO OPEN' CORRECTION: D10, H3. H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD 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 BD. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A FOLEY ISSUE REPORTED AT MUSC ON (B)(6) 2019 BY THE 8D CHILDRENS FLOOR. THE 8 FR. FOLEY WITH LOT # NGCZ2377. THE RN WAS MET WITH RESISTANCE WHILE INSERTING WATER INTO THE BALLOON. UPON REMOVAL A PINHOLE WAS FOUND IN THE BALLOON. THERE WAS NO PATIENT HARM REPORTED. PER FOLLOW UP WITH THE SALES REP ON 6FEB2020, HE CONFIRMED THAT WHEN HE FOLLOWED UP IN PERSON HE WAS MADE AWARE OF THIS EVENT ON (B)(6)2020.

    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 FOLEY ISSUE REPORTED AT (B)(6) ON (B)(6) 2019 BY THEIR 8D CHILDRENS FLOOR. THE 8 FR. FOLEY WITH LOT # NGCZ2377. THE RN WAS MET WITH RESISTANCE WHILE INSERTING WATER INTO THE BALLOON. UPON REMOVAL A PINHOLE WAS FOUND IN THE BALLOON. THERE WAS NO PATIENT HARM REPORTED. PER FOLLOW UP WITH THE SALES REP ON 6FEB2020, HE CONFIRMED THAT WHEN HE FOLLOWED UP IN PERSON HE WAS MADE AWARE OF THIS EVENT ON (B)(6) 2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178209 BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER FOLEY CATHETER EZL C.R. BARD, INC. (COVINGTON) -1018233 175808 NGCZ2377 00801741034275

    Patients

    Seq Age Sex Outcome Treatment
    1