BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALL SILICONE CATHETER

    MDR report key: 15199666 · Received August 10, 2022

    Report

    Report Number
    1018233-2022-06251
    Event Type
    Malfunction
    Date Received
    August 10, 2022
    Date of Event
    July 28, 2022
    Report Date
    November 3, 2022
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EZL
    PMA / PMN Number
    K040504
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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 INCONCLUSIVE BECAUSE NO SAMPLE WAS RETURNED. A POTENTIAL ROOT CAUSE FOR THIS FAILURE COULD BE DUE TO "INCORRECT PUNCHING DIE". IT IS UNKNOWN WHETHER THE DEVICE HAD MET RELEVANT SPECIFICATIONS. THE PRODUCT WAS USED FOR TREATMENT PURPOSES. IT WAS UNKNOWN WHETHER THE PRODUCT HAD CAUSED THE REPORTED FAILURE. THE LOT NUMBER WAS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE PRODUCT CATALOG NUMBER AND THE LOT NUMBER FOR THIS DEVICE ARE UNKNOWN. THEREFORE, BD IS UNABLE TO DETERMINE THE ASSOCIATED LABELING TO REVIEW. 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 DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FOLEY CATHETER WAS NOT DRAINING AS WELL AS CAUSING PATIENT DISCOMFORT AND FEELINGS OF BEING FULL. WHEN REGISTERED NURSE WAS DOING IN AND OUT THEY FELT LIKE THEY HAVE TO TIP THAT UP AND DOWN A LOT TO GET ACCURATE HOURLY CHECK AND FELT LIKE THAT COULD NOT BE GOOD FOR URINARY TRACT INFECTION. STATED THAT IT SEEMED LIKE THE DIAMETER WAS SMALLER THAT MIGHT BE CAUSING SOME OF THAT. REPRESENTATIVE MENTIONED THAT SMALLER DIAMETER MIGHT BE CAUSING THE POOR DRAINAGE WHICH THEY MENTIONED AND MIGHT BE THE FRENCH SIZE THEY WERE USING WAS SMALLER THAN THE PREVIOUS CATHETER. HAVING TO TIP THE METER INTO THE BAG WOULD NOT CAUSE REFLUX OF URINE INTO THE TUBING, THEY SIMPLY LIFT THE PLASTIC METER AND IT EMPTIED INTO THE BAG. REPRESENTATIVE ALSO MENTIONED ABOUT SCHEDULING SOME SORT OF EDUCATION FOR THE STAFF. ON (B)(6) 2022 CUSTOMER ALSO STATED THAT THEIR CLINICAL TEAM WHEN INSERTING THE FOLEY TUBING WAS KINKING AND COILING. STATED THAT THEY WERE TRANSITIONING TO BOTH THE 14 AND 16 FOLEY KITS - TEMPERATURE SENSING AND NON TEMPERATURE SENSING. ALSO THEY WERE IN THE BEGINNING OF TRANSITIONING OVER TO BD FOLEY LINE AND INQUIRED THAT THE ISSUES THEY WERE EXPERIENCING MIGHT BE A SIMPLE EDUCATION SENT OUT OR MIGHT REQUIRE A IN PERSON EDUCATION. UPON DISCUSSION WITH THE CUSTOMER ON (B)(6)2022, REPRESENTATIVE ON STATED THAT THE DRAINAGE EYES WERE SMALLER ON SILICONE CATHETERS AND THAT ISSUE WITH THE BAG MIGHT BE A VAPOR LOCK. THE SOLUTION WAS TO HAVE THE NURSE PULL THE METER AWAY FROM THE BAG AND BEND THE SPINE TO ALLOW AIR TO FLOW WHICH WOULD HELP WITH DRAINING. ALSO STATED THAT SOMETIME WHAT COULD HAPPEN WITH VAPOR LOCK WAS THE URINE WOULD STILL IN THE TUBING AND NOT DRAIN PROPERLY. MEDICAL INFORMATION TEAM MENTIONED THAT THE LATEX FOLEY CATHETERS DID OFFER MORE DRAINAGE OR FOLEYS WITH MORE OR LARGER EYES. ALSO EXERCISING THE BAGS BEFORE USE WOULD ALLOW URINE TO FLOW INTO THE BAG EASIER, ALONG WITH MAKING SURE THE BAG WAS BELOW THE BLADDER. NO MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE FOLEY CATHETER WAS NOT DRAINING AS WELL AS CAUSING PATIENT DISCOMFORT AND FEELINGS OF BEING FULL. WHEN REGISTERED NURSE WAS DOING IN AND OUT THEY FELT LIKE THEY HAVE TO TIP THAT UP AND DOWN A LOT TO GET ACCURATE HOURLY CHECK AND FELT LIKE THAT COULD NOT BE GOOD FOR URINARY TRACT INFECTION. STATED THAT IT SEEMED LIKE THE DIAMETER WAS SMALLER THAT MIGHT BE CAUSING SOME OF THAT. REPRESENTATIVE MENTIONED THAT SMALLER DIAMETER MIGHT BE CAUSING THE POOR DRAINAGE WHICH THEY MENTIONED AND MIGHT BE THE FRENCH SIZE THEY WERE USING WAS SMALLER THAN THE PREVIOUS CATHETER. HAVING TO TIP THE METER INTO THE BAG WOULD NOT CAUSE REFLUX OF URINE INTO THE TUBING, THEY SIMPLY LIFT THE PLASTIC METER AND IT EMPTIED INTO THE BAG. REPRESENTATIVE ALSO MENTIONED ABOUT SCHEDULING SOME SORT OF EDUCATION FOR THE STAFF. ON 26JUL2022 CUSTOMER ALSO STATED THAT THEIR CLINICAL TEAM WHEN INSERTING THE FOLEY TUBING WAS KINKING AND COILING. STATED THAT THEY WERE TRANSITIONING TO BOTH THE 14 AND 16 FOLEY KITS - TEMPERATURE SENSING AND NON TEMPERATURE SENSING. ALSO THEY WERE IN THE BEGINNING OF TRANSITIONING OVER TO BD FOLEY LINE AND INQUIRED THAT THE ISSUES THEY WERE EXPERIENCING MIGHT BE A SIMPLE EDUCATION SENT OUT OR MIGHT REQUIRE A IN PERSON EDUCATION. UPON DISCUSSION WITH THE CUSTOMER ON 28JUL2022, REPRESENTATIVE ON STATED THAT THE DRAINAGE EYES WERE SMALLER ON SILICONE CATHETERS AND THAT ISSUE WITH THE BAG MIGHT BE A VAPOR LOCK. THE SOLUTION WAS TO HAVE THE NURSE PULL THE METER AWAY FROM THE BAG AND BEND THE SPINE TO ALLOW AIR TO FLOW WHICH WOULD HELP WITH DRAINING. ALSO STATED THAT SOMETIME WHAT COULD HAPPEN WITH VAPOR LOCK WAS THE URINE WOULD STILL IN THE TUBING AND NOT DRAIN PROPERLY. MEDICAL INFORMATION TEAM MENTIONED THAT THE LATEX FOLEY CATHETERS DID OFFER MORE DRAINAGE OR FOLEYS WITH MORE OR LARGER EYES. ALSO EXERCISING THE BAGS BEFORE USE WOULD ALLOW URINE TO FLOW INTO THE BAG EASIER, ALONG WITH MAKING SURE THE BAG WAS BELOW THE BLADDER. NO MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1522457 ALL SILICONE CATHETER SILICONE CATHETER EZL C.R. BARD, INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other