BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 16655768 · Received March 31, 2023

    Report

    Report Number
    1018233-2023-02205
    Event Type
    Malfunction
    Date Received
    March 31, 2023
    Date of Event
    February 21, 2023
    Report Date
    April 20, 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.

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS UNCONFIRMED BECAUSE THE REPORTED FAILURE COULD NOT BE REPRODUCED. THE REPORTED FAILURE IS WITHIN SPECIFICATION AS THE REPORTED FAILURE COULD NOT BE REPRODUCED. THE PRODUCT WAS USED FOR PATIENT TREATMENT OR DIAGNOSIS. THE PRODUCT HAD NOT CAUSED THE REPORTED FAILURE. NO ROOT CAUSE COULD BE FOUND BECAUSE THE REPORTED EVENT WAS UNCONFIRMED. VISUAL EVALUATION OF THE RETURNED SAMPLE NOTED ONE OPENED (WITHOUT ORIGINAL PACKAGING), 3 UNOPENED 3-WAY TEMP SENSING CATHETERS. VISUAL INSPECTION OF THE SAMPLE NOTED NO OBVIOUS VISIBLE DEFECTS. THE 3 CATHETER BALLOONS WERE INFLATED WITH 10ML METHYLENE BLUE SOLUTION (3 DROPS 1% AQ METHYLENE BLUE PER 100ML DISTILLED WATER) AND THE CATHETER RESTED WITH NO LEAKS NOTED. NO PINHOLE WAS NOTED ON THE BALLOONS. THE BALLOONS PASSIVELY DEFLATED WITH NO CUFFING OR LEAKS NOTED. THIS IS WITHIN SPECIFICATION PER INSPECTION PROCEDURE, WHICH STATES, CATHETER LEAKS, VALVE LEAKS, BALLOON PERFORATION, LUMEN TO LUMEN, PREMATURELY DEFLATED AND DISLODGED BALLOON ARE NOT ALLOWED, AND MUST INFLATE AND DEFLATE WITH THE USE OF A SYRINGE. THE DEVICE HISTORY RECORD WAS REVIEWED AND FOUND NOTHING THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. AS THE REPORTED EVENT IS UNCONFIRMED A LABELING REVIEW IS NOT REQUIRED. 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 12MAR2023 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. PER FOLLOW-UP INFORMATION RECEIVED FROM IBC ON 15MAR2023, STATED THAT THERE WAS NO BALLOON RUPTURE. THE CATHETER HAD A BALLOON PINHOLE.

    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 12MAR2023 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. PER FOLLOW-UP INFORMATION RECEIVED FROM IBC ON 15MAR2023, STATED THAT THERE WAS NO BALLOON RUPTURE. THE CATHETER HAD A BALLOON PINHOLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581131 BARDEX® LUBRI-SIL® I.C. ALL-SILICONE TEMP SENSING FOLEY CATHETER FOLEY CATHETER MJC C.R. BARD, INC. (COVINGTON) -1018233 119314 NGGT3722 00801741039843

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other