BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN SILICONE TEMP-SENSING CATHETER

    MDR report key: 15216455 · Received August 12, 2022

    Report

    Report Number
    1018233-2022-06318
    Event Type
    Malfunction
    Date Received
    August 12, 2022
    Date of Event
    July 20, 2022
    Report Date
    August 26, 2022
    Manufacturer
    C.R. BARD, INC. (COVINGTON) -1018233
    Product Code
    EZL
    PMA / PMN Number
    K070582
    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

    UPON FURTHER REVIEW, BD HAS DETERMINED THAT THIS MDR WAS REPORTED IN ERROR AS IT WAS FOUND THAT THERE IS NO ALLEGATION AGAINST PRODUCT.

    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. IT WAS 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. CUSTOMER ALSO STATED THAT THEIR CLINICAL TEAM WHEN INSERTING THE FOLEY TUBING WAS KINKING AND COILING . IT WAS 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, REPRESENTATIVE 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.

    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. IT WAS 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. CUSTOMER ALSO STATED THAT THEIR CLINICAL TEAM WHEN INSERTING THE FOLEY TUBING WAS KINKING AND COILING . IT WAS 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, REPRESENTATIVE 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2433431 UNKNOWN SILICONE TEMP-SENSING CATHETER TEMPERATURE SENSING CATHETER EZL C.R. BARD, INC. (COVINGTON) -1018233 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other