BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC* TJ FEEDING TUBE KIT 18 FR, 45CM (ENDO/RADIOL)

    MDR report key: 4933007 · Received July 22, 2015

    Report

    Report Number
    9611594-2015-00124
    Event Type
    Malfunction
    Date Received
    July 22, 2015
    Date of Event
    July 22, 2015
    Report Date
    August 12, 2015
    Manufacturer
    HALYARD HEALTH
    Product Code
    KGC
    PMA / PMN Number
    PK080253
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE WAS NOT RETURNED. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER WAS REVIEWED AND DOCUMENTED THAT THE LOT WAS MANUFACTURED ACCORDING TO THE APPROVED MANUFACTURING PROCEDURES, SPECIFICATIONS, AND THEN RELEASED BY QUALITY ASSURANCE. 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)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION; A FOLLOW-UP REPORT WILL BE FILED. 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 (B)(4). DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    THIS IS THE FIRST OF TWO REPORTS FOR THE SAME PATIENT INVOLVING TWO SEPARATE PRODUCTS. REFER TO REPORT 9611594-2015-00151 FOR THE SECOND REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FEEDING TUBE SPLIT BELOW THE GASTRIC PORT. THE TUBE WAS IN PLACE FOR APPROXIMATELY ONE MONTH. THE TUBE WAS REPLACED IN RADIOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476835 MIC* TJ FEEDING TUBE KIT 18 FR, 45CM (ENDO/RADIOL) DH EF BALLOON TUBES PRODUCTS KGC HALYARD HEALTH 0250-18 AA5005N03

    Patients

    Seq Age Sex Outcome Treatment
    1