BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADDER CATHETER

    MDR report key: 8790886 · Received July 15, 2019

    Report

    Report Number
    8040412-2019-00201
    Event Type
    Malfunction
    Date Received
    July 15, 2019
    Date of Event
    July 4, 2019
    Report Date
    July 15, 2019
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    EZL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). INITIAL REPORT SUBMITTED WAS SUBMITTED UNDER AN INCORRECT MANUFACTURER REPORT NUMBER. THE MANUFACTURER REPORT NUMBER SHOULD BE CHANGED TO 9610520-2019-00018.

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE COMPLAINT IS REGARDING 1 BLADDER CATHETER, NELATON-ROBINSON, P/N 220500 WHERE THE CUSTOMER REPORTED THAT AFTER INSERTION OF THE CATHETER A TEAR WAS NOTED NEAR THE FUNNEL, WHERE THE URINE LEAKED. THE ACTUAL DEVICE AND 16 ADDITIONAL SAMPLES FROM THE SAME LOT WERE RETURNED FOR INVESTIGATION. A FUNCTIONAL INVESTIGATION OF THE 17 DEVICES WAS CONDUCTED ACCORDING TO THE EFFECTIVE WORK INSTRUCTION FOR THE TIGHTNESS TEST FUNNEL-TUBE. THE REPORTED COMPLAINT ERROR PICTURE COULD BE CONFIRMED ON 3 SAMPLES. THE REMAINING 14 SAMPLES SHOWED NO IRREGULARITIES. A REVIEW OF THE MANUFACTURING DATA FOR LOT 18/28/212 WAS CARRIED OUT AND NO ISSUES THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT WERE IDENTIFIED. THE PERFORMED IN-PROCESS-CONTROLS TO WHICH ALSO A LEAK TEST BELONGS, SHOWED NO DEVIATIONS. OUR INVESTIGATION CONFIRMED THE REPORTED ISSUE FOR 3 SAMPLES. HOWEVER , IN THE ROOT CAUSE ANALYSIS, NO CLEAR CAUSE FOR THE FAILURE COULD BE DETERMINED. THE REPORTED SLIGHT LEAKAGE BETWEEN FUNNEL AND CATHETER TUBE OCCURS SPORADICALLY, WHICH IS AN INCONVENIENCE FOR THE USER AND MEANS NO USER RISK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER INSERTION OF THE CATHETER A TEAR NEAR THE FUNNEL WAS NOTED, WHERE URINE RUN OUT. THE CUSTOMER REPORTED THAT THIS OCCURRED SEVERAL TIMES. HOWEVER, THE EXACT NUMBER OF OCCURRENCES IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER INSERTION OF THE CATHETER A TEAR NEAR THE FUNNEL WAS NOTED, WHERE URINE RUN OUT. THE CUSTOMER REPORTED THAT THIS OCCURRED SEVERAL TIMES. HOWEVER, THE EXACT NUMBER OF OCCURRENCES IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE INVESTIGATION IS PENDING. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER INSERTION OF THE CATHETER A TEAR NEAR THE FUNNEL WAS NOTED, WHERE URINE RUN OUT. THE CUSTOMER REPORTED THAT THIS OCCURRED SEVERAL TIMES. HOWEVER, THE EXACT NUMBER OF OCCURRENCES IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584220 BLADDER CATHETER EZL TELEFLEX MEDICAL 18/28/212

    Patients

    Seq Age Sex Outcome Treatment
    1