BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX® LUBRI-SIL® ALL-SILICONE TEMP SENSING FOLEY CATHETER

    MDR report key: 9403110 · Received December 3, 2019

    Report

    Report Number
    1018233-2019-07665
    Event Type
    Malfunction
    Date Received
    December 3, 2019
    Report Date
    December 12, 2019
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EZL
    UDI-DI
    00801741046308
    PMA / PMN Number
    K070582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. DEVICE HAD MET SPECIFICATIONS DUE TO NO SAMPLE WAS RETURNED FOR EVALUATION. THE PRODUCT WAS USED FOR TREATMENT PURPOSES. A POTENTIAL FAILURE MODE COULD BE ¿BURST BALLOONS¿ WITH A POTENTIAL ROOT CAUSE OF ¿HIGH MODULUS LATEX AND NON-UNIFORM THIN SAC AND /OR FINISH DIP COVERAGE¿. THE LOT NUMBER IS UNKNOWN THEREFORE THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: ¿C. R. BARD, INC. (B)(4). MANUFACTURED IN MEXICO LUBRI-SIL® 100% LATEX-FREE 400-SERIES TEMPERATURE-SENSING HYDROGEL COATED FOLEY CATHETER PK7602482 11/2006 BARD AND LUBRI-SIL ARE REGISTERED TRADEMARKS OF C. R. BARD, INC. OR AN AFFILIATE. TO DEFLATE CATHETER BALLOON: GENTLY INSERT A 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. PEEL TO OPEN PEEL TO OPEN FOR UROLOGICAL USE ONLY SINGLE USE ONLY DO NOT RESTERILIZE NOTE: COMPATIBLE WITH APPROPRIATE 400-SERIES TEMPERATURE MONITORS. INTERCHANGEABILITY + 0.2OC AT 37OC. CAUTION: AS WITH ALL TEMPERATURE PROBES: IN THE PRESENCE OF RF ENERGY SOURCES: LOCAL HEATING, TEMPERATURE ERRORS, AND PROBE DAMAGE MAY OCCUR. IN MEDICAL USE, UNPLUG THE TEMPERATURE-SENSING CATHETER AT THE EXTENSION CABLE BEFORE ACTIVATING ELECTROSURGICAL OR OTHER TYPES OF DIRECT COUPLED RF ENERGY SOURCES. DO NOT STRETCH CATHETER. THIS WILL CAUSE REPOSITIONING OF PROBE. DO NOT USE STYLET. THIS WILL CAUSE STRETCHING OF CATHETER. VALVE TYPE: USE LUER SLIP SYRINGE. DO NOT USE NEEDLE. CAUTION: FEDERAL (U.S.A.) LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN. STERILE: 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. RECOMMENDED INFLATION CAPACITIES 8 FR. AND 10 FR. (3CC BALLOON): USE 3.5CC STERILE WATER 12 FR. (5CC BALLOON): USE 5.5CC STERILE WATER 14 FR. AND LARGER (5CC BALLOON): USE 10CC STERILE WATER DO NOT EXCEED RECOMMENDED CAPACITIES. CAUTION: AGGRESSIVE TRACTION, PARTICULARLY IN THE PRESENCE OF SUTURING, IS NOT RECOMMENDED FOR 100% SILICONE FOLEY CATHETERS. WARNING: AFTER USE, THIS PRODUCT MAY BE A POTENTIAL BIOHAZARD. HANDLE AND DISPOSE OF IN ACCORDANCE WITH APPLICABLE LAWS AND REGULATIONS. WARNING: THIS PRODUCT SHOULD NEVER BE CONNECTED TO THE TEMPERATURE MONITOR OR CONNECTED TO A CABLE DURING AN MRI PROCEDURE. FAILURE TO FOLLOW THIS GUIDELINE MAY RESULT IN SERIOUS INJURY TO THE PATIENT. REFER TO THE INSTRUCTIONS FOR USE. IT IS IMPORTANT TO CLOSELY FOLLOW THESE SPECIFIC CONDITIONS THAT HAVE BEEN DETERMINED TO PERMIT THE EXAMINATION TO BE CONDUCTED SAFELY. ANY DEVIATION MAY RESULT IN A SERIOUS INJURY TO THE PATIENT. MR RELEASED"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FOLEY BALLOON BURST MID CASE AND STOPPED DRAINING URINE.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FOLEY BALLOON BURST MID CASE AND STOPPED DRAINING URINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1202099 BARDEX® LUBRI-SIL® ALL-SILICONE TEMP SENSING FOLEY CATHETER LUBRISIL TEMP SENSING CATHETER EZL C.R. BARD, INC. (COVINGTON) -1018233 119216M UNK 00801741046308

    Patients

    Seq Age Sex Outcome Treatment
    1