BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12431000 · Received September 6, 2021

    Report

    Report Number
    1018233-2021-05450
    Event Type
    Malfunction
    Date Received
    September 6, 2021
    Date of Event
    July 28, 2021
    Report Date
    March 16, 2022
    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 REPORTED EVENT WAS UNCONFIRMED BECAUSE THE REPORTED FAILURE COULD NOT BE REPRODUCED. THE DEVICE MET RELEVANT SPECIFICATIONS. THE PRODUCT WAS USED FOR TREATMENT. THE PRODUCT HAD NOT CAUSED THE REPORTED FAILURE. VISUAL EVALUATION OF THE RETURNED SAMPLE NOTED ONE OPENED (WITHOUT ORIGINAL PACKAGING), USED TEMPERATURE SENSING SILICONE FOLEY CATHETER. VISUAL INSPECTION OF THE SAMPLE NOTED NO OBVIOUS VISIBLE DEFECTS. THE CATHETER BALLOON WAS INFLATED WITH 10 ML METHYLENE BLUE SOLUTION (3 DROPS 1% AQ METHYLENE BLUE PER 100ML DISTILLED WATER), AND SOLUTION IMMEDIATELY LEAKED FROM A 0.012" PINHOLE FOUND ON THE BALLOON SURFACE. THIS IS OUT OF SPECIFICATION PER INSPECTION PROCEDURE WHICH STATES, "PINHOLES ARE NOT PERMITTED". FURTHER, THE CATHETER WAS FLUSHED TO TEST FOR RESTRICTED FLOWRATE, AND THERE WERE NO OBSTRUCTIONS NOTED. THIS MEET SPECIFICATION PER INSPECTION PROCEDURE WHICH STATES, "CHECK FOR DEFECTS: EXCESSIVE MATERIAL (OVER FILL), BUBBLES/VOIDS, SPLITS AND/OR BLEMISHES. NO ROOT CAUSE COULD BE FOUND BECAUSE THE REPORTED EVENT WAS UNCONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW ANY PROBLEMS OR CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED ISSUE. THE INVESTIGATION IS CONCLUDED, AND NO ADDITIONAL ACTION IS REQUIRED AT THIS TIME. 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 AND RISK REVIEW IS NOT REQUIRED. H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BARD 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 BARD. H3 OTHER TEXT : THE ACTUAL/SUSPECTED DEVICE WAS INSPECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FOLEY CATHETER WAS PULLED OUT AFTER THE OPERATION, WHEN THE OIF WAS REMOVED . THE PATIENT STATED THAT THE CATHETER WAS REINSERTED AND THE URINE FLOW WAS GOOD. WHEN THEY CHECKED THE BALLOON CATHETER THAT HAD BEEN PULLED OUT, IT WAS FOUND THAT THERE WAS A SMALL HOLE IN THE CUFF PART, AND DISTILLED WATER FOR INDWELLING LEAKED OUT. IT IS UNKNOWN WHEN IT CAME OUT. A CUFF CHECK WAS PERFORMED BEFORE THE BALLOON CATHETER WAS INSERTED BEFORE THE OPERATION, AND THE CATHETER WAS INSERTED WITHOUT ANY PROBLEM. GOOD URINE FLOW WAS CONFIRMED, DISTILLED WATER FROM THE CUFF WAS ALSO INJECTED WITHOUT RESISTANCE, AND IT WAS FIXED WITH TAPE SO THAT IT WOULD NOT COME OFF. BLADDER TEMPERATURE FROM 36.2 ° C TO 35.6 ° C DURING SURGERY AND OBSERVED AFTER THAT. THEY REPORTED TO THE ANESTHESIOLOGIST TO MEASURE THE ESOPHAGEAL TEMPERATURE, AND OBSERVING THE TEMPERATURE WAS 35.6 ° C. THE DRAIN BAG MISSED THE URINE AFTER SURGERY AND THEY THOUGHT URINE VOLUME WOULD NOT INCREASE ON THE WAY. ALSO THE INDWELLING BAG THAT HAD BEEN MISSED CONTAINED 170 ML OF URINE. AFTER REPLACEMENT, 500 ML SPILLED INTO A NEW INDWELLING BAG, FOR A TOTAL URINE VOLUME OF 670 ML. WHEN USING A BALLOON CATHETER WITH A BLADDER TEMPERATURE SENSOR IN THE FUTURE, IT WAS ADVISED TO CHECK WHETHER THE CATHETER HAS COME OFF WHEN THE BLADDER TEMPERATURE DROPS. NO PATIENT INJURY WAS REPORTED.

    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 THE FOLEY CATHETER WAS PULLED OUT AFTER THE OPERATION, WHEN THE OIF WAS REMOVED . THE PATIENT STATED THAT THE CATHETER WAS REINSERTED AND THE URINE FLOW WAS GOOD. WHEN THEY CHECKED THE BALLOON CATHETER THAT HAD BEEN PULLED OUT, IT WAS FOUND THAT THERE WAS A SMALL HOLE IN THE CUFF PART, AND DISTILLED WATER FOR INDWELLING LEAKED OUT. IT IS UNKNOWN WHEN IT CAME OUT. A CUFF CHECK WAS PERFORMED BEFORE THE BALLOON CATHETER WAS INSERTED BEFORE THE OPERATION, AND THE CATHETER WAS INSERTED WITHOUT ANY PROBLEM. GOOD URINE FLOW WAS CONFIRMED, DISTILLED WATER FROM THE CUFF WAS ALSO INJECTED WITHOUT RESISTANCE, AND IT WAS FIXED WITH TAPE SO THAT IT WOULD NOT COME OFF. BLADDER TEMPERATURE FROM 36.2 ° C TO 35.6 ° C DURING SURGERY AND OBSERVED AFTER THAT. THEY REPORTED TO THE ANESTHESIOLOGIST TO MEASURE THE ESOPHAGEAL TEMPERATURE, AND OBSERVING THE TEMPERATURE WAS 35.6 ° C. THE DRAIN BAG MISSED THE URINE AFTER SURGERY AND THEY THOUGHT URINE VOLUME WOULD NOT INCREASE ON THE WAY. ALSO THE INDWELLING BAG THAT HAD BEEN MISSED CONTAINED 170 ML OF URINE. AFTER REPLACEMENT, 500 ML SPILLED INTO A NEW INDWELLING BAG, FOR A TOTAL URINE VOLUME OF 670 ML. WHEN USING A BALLOON CATHETER WITH A BLADDER TEMPERATURE SENSOR IN THE FUTURE, IT WAS ADVISED TO CHECK WHETHER THE CATHETER HAS COME OFF WHEN THE BLADDER TEMPERATURE DROPS. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1325697 BARDEX® LUBRI-SIL® I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER TEMPERATURE SENSING FOLEY CATHETER MJC C.R. BARD, INC. (COVINGTON) -1018233 119314 NGEU0840 00801741039843

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other