BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADDER CATHETER, PVC, NELATON-ROBINSON

    MDR report key: 9446987 · Received December 10, 2019

    Report

    Report Number
    9610520-2019-00026
    Event Type
    Malfunction
    Date Received
    December 10, 2019
    Date of Event
    October 27, 2019
    Report Date
    November 12, 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 · 1

    (B)(4). THE COMPLAINT IS REGARDING 6 BLADDER CATHETERS, NELATON-ROBINSON WITH P/N 220500 WHERE CUSTOMER REPORTED THAT CATHETER SHAFT LEAKED - DEVICES WERE TESTED PRIOR TO USE AND ALL 6 CATHETERS SHOWED A LEAKAGE. THE ACTUAL 6 DEVICES WERE RETURNED FOR INVESTIGATION. A LEAK TEST ACCORDING TO THE EFFECTIVE WORK INSTRUCTION FOR THE TIGHTNESS TEST BETWEEN FUNNEL AND TUBE WAS PERFORMED ON ALL 6 SAMPLES. THE FUNCTIONAL TEST CONFIRMED A LEAK IN EACH OF THE 6 SAMPLES. THE LEAK OCCURS BETWEEN THE CATHETER TUBE AND THE FUNNEL. IN ADDITION, A REVIEW FOR THE PRODUCTION DATA FOR LOT 18/28/212 WAS PERFORMED. 6,550 CATHETERS WERE GLUED BY THE FUNNEL-GLUING-MACHINE NO. 4. THE PERFORMED IN-PROCESS CONTROL WHICH ALSO INCLUDED A LEAK TEST REVEALED NO DEVIATIONS DURING THE PRODUCTION OF THE CLAIMED LOT. BASED ON THE INVESTIGATION, THE SUPPLIER CONFIRMED THE REPORTED ISSUE FOR THE 6 ACTUAL SAMPLES. A NC HAS BEEN OPENED BY THE SUPPLIER, BUT NOT CLEAR CAUSE FOR THIS FAILURE COULD BE DETERMINED. THE REPORTED FAILURE BETWEEN FUNNEL AND CATHETER TUBE OCCURS SPORADICALLY AND THIS IS AN INCONVENIENCE FOR THE USER BUT NO RISK FOR THE USER. DURING THE IN-PROCESS CONTROL, THE CONNECTION IS TESTED AT 1 BAR PRESSURE AND NO DEVIATION WAS REPORTED FOR THIS LOT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND RELATED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER SHAFT LEAKED. DEVICES WERE TESTED PRIOR TO USE AND ALL 6 CATHETERS SHOWED A LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243463 BLADDER CATHETER, PVC, NELATON-ROBINSON KOD TELEFLEX MEDICAL 18/28/212

    Patients

    Seq Age Sex Outcome Treatment
    1