BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADDER CATHETER,NELAT.-ROB.,SIZ.10

    MDR report key: 9191845 · Received October 15, 2019

    Report

    Report Number
    9610520-2019-00023
    Event Type
    Malfunction
    Date Received
    October 15, 2019
    Date of Event
    September 1, 2019
    Report Date
    September 20, 2019
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    KOD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). EACH OF THE 5 COMPLAINTS IS REGARDING 1 BLADDER CATHETER, NELATON-ROBINSON, P/N 220500 WHERE THE CUSTOMER REPORTED THAT THE CATHETER LEAKED AT THE FUNNEL DURING USE. FOR THE 5 COMPLAINTS (B)(4), ALL IN ALL 3 ACTUAL DEVICES AND 1 REPRESENTATIVE SAMPLE FROM THE SAME LOT WERE RETURNED FOR INVESTIGATION. A LEAK TEST WAS PERFORMED ON THE 3 ACTUAL SAMPLES BY CONNECTING A 1.5 L URINE BAG FILLED WITH WATER TO THE CATHETER. THE FUNCTIONAL TEST CONFIRMED FOR THE 3 SAMPLES A LEAK BETWEEN CATHETER TUBE AND FUNNEL. FURTHERMORE, A FUNCTIONAL INVESTIGATION OF THE REPRESENTATIVE DEVICE WAS CONDUCTED ACCORDING TO THE EFFECTIVE WORK INSTRUCTION FOR THE TIGHTNESS TEST BETWEEN FUNNEL AND TUBE. THE REPRESENTATIVE SAMPLE SHOWED NO LEAK AT THE ADHESIVE CONNECTION BETWEEN TUBE AND FUNNEL. 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. FOR INVESTIGATION A NC HAS BEEN OPENED. THE EXAMINATION CONFIRMED THE REPORTED ISSUE FOR THE 3 ACTUAL SAMPLES. HOWEVER, IN THE ROOT CAUSE ANALYSIS, NO CLEAR CAUSE FOR THE FAILURE COULD BE DETERMINED. THE NC ALSO INCLUDES 3 FORMER CONFIRMED COMPLAINTS (TC#(B)(4)) WITH THE FAILURE "LEAK BETWEEN FUNNEL AND TUBE" FOR THE REPORTED LOT 18/12/212. 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 THE CATHETER LEAKED AT THE FUNNEL DURING USE.

    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 THE CATHETER LEAKED AT THE FUNNEL DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983876 BLADDER CATHETER,NELAT.-ROB.,SIZ.10 KOD TELEFLEX MEDICAL 18/28/212

    Patients

    Seq Age Sex Outcome Treatment
    1