BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXI-SEAL FMS-FECAL MANAGEMENT SYSTEM KIT

    MDR report key: 3703070 · Received January 9, 2014

    Report

    Report Number
    2243969-2014-00010
    Event Type
    Malfunction
    Date Received
    January 9, 2014
    Date of Event
    December 8, 2013
    Report Date
    December 11, 2013
    Manufacturer
    CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, L.L.C.
    Product Code
    KNT
    PMA / PMN Number
    K032734
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO PROVIDED THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. NO ADD'L PT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. THE LOT NUMBER WAS NOT PROVIDED. THEREFORE, WE ARE UNABLE TO DETERMINE THE SPECIFIC THIRD PARTY MANUFACTURING SITE. BOTH POTENTIAL MANUFACTURING SITE NUMBERS ARE LISTED BELOW. A RETURN SAMPLE FOR EVAL IS NOT EXPECTED. SHOULD ADD'L INFO BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    A NURSE REPORTED THE LUER LOCK AT THE INFLATION PORT WAS BROKEN OFF. UNABLE TO ATTACH SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17947 FLEXI-SEAL FMS-FECAL MANAGEMENT SYSTEM KIT GASTROINTESTINAL TUBE AND ACCESSORIES KNT CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, L.L.C. 41800 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1