BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSGASTRIC JEJUNAL, 22F.

    MDR report key: 4862468 · Received June 23, 2015

    Report

    Report Number
    9611594-2015-00099
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    May 6, 2015
    Report Date
    May 28, 2015
    Manufacturer
    HALYARD HEALTH
    Product Code
    KNT
    PMA / PMN Number
    PK921370
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THE LOT NUMBER INVOLVED IN THIS COMPLAINT WAS REVIEWED AND THE MATERIAL WAS PRODUCED ACCORDING TO THE MANUFACTURING PROCEDURES AND MET THE QUALITY REQUIREMENTS. THE ACTUAL COMPLAINT PRODUCT WAS RETURNED FOR EVALUATION WITH A LOT NUMBER. THE BALLOON ON THE SAMPLE DEVICE EXHIBITED AN AXIAL BURST, EXTENDING FROM THE BASE OF THE PROXIMAL COLLAR TO THE BASE OF THE DISTAL COLLAR. THE BALLOON MATERIAL WAS INSPECTED UNDER MAGNIFICATION. NO OBVIOUS DEFECT WAS OBSERVED ON THE MATERIAL THAT COULD IDENTIFY A POTENTIAL POINT OF ORIGIN FOR THE BURST. THE TUBE PREPARATION INSTRUCTIONS IN THE DIRECTIONS FOR USE STATE, "(5)LUBRICATE THE DISTAL END OF THE TUBE WITH WATER-SOLUBLE LUBRICANT. DO NOT USE MINERAL OIL OR PETROLEUM JELLY. (6) GENEROUSLY LUBRICATE THE JEJUNAL LUMEN WITH WATER-SOLUBLE LUBRICANT. DO NOT USE MINERAL OIL OR PETROLEUM JELLY." HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(6).

    Description of Event or Problem · 1

    A REPORT WAS RECEIVED FROM (B)(6) STATING THE TRANSGASTRIC ENTERAL FEEDING TUBE BALLOON HAD A TEAR. THE DEVICE WAS IN USE FOR THREE WEEKS PRIOR TO THE EVENT. AN UNSPECIFIED LUBRICANT WAS USED DURING PLACEMENT OF THE DEVICE. THE DEVICE WAS REPLACED DURING A RADIOLOGY PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406302 TRANSGASTRIC JEJUNAL, 22F. ENTERAL FEEDING TUBE KNT HALYARD HEALTH 0650-22 AA4091N50

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention