BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANDERSON AN10-S (AN10.11)

    MDR report key: 2823664 · Received April 13, 2010

    Report

    Report Number
    1053825-2010-00002
    Event Type
    Malfunction
    Date Received
    April 13, 2010
    Date of Event
    March 14, 2010
    Report Date
    April 13, 2010
    Manufacturer
    ANDERSEN PRODUCTS
    Product Code
    BSS
    PMA / PMN Number
    K935688
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALL TUBES MFG IN THIS LOT (290208) WERE 100% INSPECTED FOR LEAK TESTING. IT IS UNK WHY THE TWO TUBES LEAKED AND THE RESULTS COULD NOT BE DUPLICATED.

    Description of Event or Problem · 1

    PT WAS INCUBATED WITH AN AN10.11 AND THE TUBE STARTED TO LEAK AROUND THE MOLDED PLASTIC CONNECTOR. THE TUBE WAS REMOVED. ANOTHER TUBE FROM THE SAME LOT WAS INCUBATED AND THE SAME PROBLEM OCCURRED AND THAT TUBE WAS ALSO REMOVED. NO HARM WAS CAUSED TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANDERSON AN10-S (AN10.11) AN10-S BSS ANDERSEN PRODUCTS AN10-S 290208

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK