BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARDEX® LUBRI-SIL® I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER

    MDR report key: 16655766 · Received March 31, 2023

    Report

    Report Number
    1018233-2023-02206
    Event Type
    Malfunction
    Date Received
    March 31, 2023
    Date of Event
    February 21, 2023
    Report Date
    April 19, 2023
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    MJC
    UDI-DI
    00801741039843
    PMA / PMN Number
    K070582
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    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. 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 CONFIRMED CAUSE UNKNOWN. ONE SAMPLE EXHIBITED THE REPORTED FAILURE. THE DEVICE HAD NOT MET SPECIFICATIONS. THE REPORTED FAILURE IS CONSIDERED OUT OF SPECIFICATION AS THE REPORTED FAILURE WAS REPRODUCED. THE PRODUCT WAS USED FOR PATIENT TREATMENT OR DIAGNOSIS. THE PRODUCT CAUSED THE REPORTED FAILURE. ALTHOUGH A SPECIFIC CAUSE CANNOT BE DETERMINED, BASED ON THE RISK DOCUMENT A POTENTIAL ROOT CAUSE FOR THIS EVENT COULD BE IMPERFECTION IN BALLOON DUE TO PROCESS. 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: [WARNINGS] 1. METHOD FOR USE (1) DO NOT INFLATE THE BALLOON IN THE URETHRA. [THE URETHRA MAY BE INJURED.] (2) DO NOT PULL THE CATHETER HARD. [THE BLADDER/URETHRA MAY BE INJURED.] 2. APPLICABLE PATIENTS ·PATIENTS WITH DELIRIUM WHO MIGHT PULL OUT CATHETER [WHEN PATIENT TUGS AT CATHETER UNCONSCIOUSLY, THE BLADDER AND URETHRA MAY BE DAMAGED.] [CONTRAINDICATIONS] 1. METHOD FOR USE: (1) DO NOT REUSE. (2) DO NOT RESTERILIZE. (3) THIS DEVICE CONTAINS 10% POVIDONE-IODINE. FOR PATIENTS WITH PAST HISTORY OF ALLERGIC HYPERSENSITIVITY TO POVIDONE-IODINE OR IODINE, CONSIDER USING ALTERNATIVE DISINFECTANTS. (4) BE CAREFUL THAT THE CATHETER IS NOT EXPOSED TO OINTMENTS, CONTRAST MEDIUM OR OIL-BASED LUBRICANTS (INCLUDING VEGETABLE OILS SUCH AS OLIVE OIL, MINERAL OILS SUCH AS WHITE PETROLATUM AND ANIMAL OILS). [THEY MAY DAMAGE THE DEVICE AND MAY BURST BALLOON.] (5) DO NOT HOLD THE DEVICE WITH FORCEPS, ETC. AVOID CONTACT WITH ANY BLADES OR SHARP-EDGED INSTRUMENTS. [CATHETER DAMAGE MAY CAUSE BALLOON RUPTURE AND ACCIDENTAL BALLOON REMOVAL OR FAILURE TO DEFLATE OR REMOVE THE BALLOON.] 2. APPLICABLE PATIENTS WITH KNOWN ALLERGY TO SILVER COATED CATHETER 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. H3 OTHER TEXT : THE ACTUAL/SUSPECTED DEVICE WAS INSPECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE NO ABNORMALITIES IN THE EXPANSION OF THE BALLOON BEFORE INSERTION, BUT AFTER INSERTION INTO THE PATIENT, THE BALLOON WAS DAMAGED AND SPONTANEOUS WITHDRAWAL OCCURRED FOUR TIMES. ALL THE EVENT WAS CONFIRMED WITH THE SAME LOT AND THE REMAINING ONE WAS COLLECTED WITHOUT BEING USED. THE USER THEN USED 29030J14 DUE TO THE LACK OF 119314. SIMILARLY, THERE WAS A REPORT DRAFTED SEPARATELY FOR SPONTANEOUS WITHDRAWAL DUE TO BALLOON DAMAGE. PER INVESTIGATOR NOTIFICATION RECEIVED VIA EMAIL ON (B)(6) 2023 STATED THAT PER SAMPLES RECEIVED. 8 SAMPLES WERE RETURNED. 4 SAMPLES NOT IN PACKAGING APPEARED TO BE USED WITH MATERIAL NUMBER 119314 AND MANUFACTURING LOT NUMBER NGGS2164. 4 SAMPLES IN UNOPENED PACKAGING WITH MATERIAL NUMBER 119314, 3 WITH BATCH NUMBER NGGT3722, AND 1 WITH BATCH NUMBER NGGS3548.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE NO ABNORMALITIES IN THE EXPANSION OF THE BALLOON BEFORE INSERTION, BUT AFTER INSERTION INTO THE PATIENT, THE BALLOON WAS DAMAGED AND SPONTANEOUS WITHDRAWAL OCCURRED FOUR TIMES. ALL THE EVENT WAS CONFIRMED WITH THE SAME LOT AND THE REMAINING ONE WAS COLLECTED WITHOUT BEING USED. THE USER THEN USED (B)(4) DUE TO THE LACK OF 119314. SIMILARLY, THERE WAS A REPORT DRAFTED SEPARATELY FOR SPONTANEOUS WITHDRAWAL DUE TO BALLOON DAMAGE. PER INVESTIGATOR NOTIFICATION RECEIVED VIA EMAIL ON (B)(6) 2023 STATED THAT PER SAMPLES RECEIVED. 8 SAMPLES WERE RETURNED. 4 SAMPLES NOT IN PACKAGING APPEARED TO BE USED WITH MATERIAL NUMBER (B)(4) AND MANUFACTURING LOT NUMBER NGGS2164. 4 SAMPLES IN UNOPENED PACKAGING WITH MATERIAL NUMBER (B)(6) , 3 WITH BATCH NUMBER (B)(4), AND 1 WITH BATCH NUMBER (B)(4) . PER FOLLOW-UP INFORMATION RECEIVED FROM IBC ON (B)(6) 2023, STATED THAT THERE WAS NO BALLOON RUPTURE. THE CATHETER HAD A BALLOON PINHOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581129 BARDEX® LUBRI-SIL® I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER FOLEY CATHETER MJC C.R. BARD, INC. (COVINGTON) -1018233 119314 NGGS2164 00801741039843

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other