BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPLACEMENT TUBE

    MDR report key: 2834075 · Received November 15, 2012

    Report

    Report Number
    1527460-2012-00086
    Event Type
    Malfunction
    Date Received
    November 15, 2012
    Report Date
    October 18, 2012
    Manufacturer
    ABBOTT NUTRITION
    Product Code
    KNT
    PMA / PMN Number
    K861323
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE BATCH HISTORY RECORD REVIEW WAS FOUND TO BE ACCURATE WITH NO ABNORMALITIES.

    Additional Manufacturer Narrative · 1

    (B)(4). ABBOTT NUTRITION STANDARD PROCEDURE INCLUDES ATTEMPTING TO OBTAIN ALL REQUIRED INFORMATION FROM THE SOURCE.

    Description of Event or Problem · 1

    ON (B)(6) 2012, RECEIVED CLARIFICATION FROM THE REPORTER THAT THE TUBE WAS IN PLACE FOR 15 DAYS.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED THE GASTROSTOMY TUBE'S BALLOON DEFLATED AND THE TUBE FELL OUT. THE TUBE HAD ONLY BEEN IN PLACE FOUR TO FIVE DAYS; HOWEVER, THE INSERTION AND REMOVAL DATES ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLACEMENT TUBE KNT ABBOTT NUTRITION 56548

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR