BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOCONNECT ENTERAL EXTENSION SET

    MDR report key: 10711138 · Received October 21, 2020

    Report

    Report Number
    10711138
    Event Type
    Malfunction
    Date Received
    October 21, 2020
    Date of Event
    September 20, 2020
    Report Date
    October 8, 2020
    Manufacturer
    NEOMED, INC.
    Product Code
    KNT
    UDI-DI
    00817584012028
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    74WE ARE REPORTING TWO FAILURES OF THE SAME PRODUCT THAT HAPPENED WITHIN 1 WEEK OF EACH OTHER: THE FEEDING TUBING WAS FOUND TO HAVE LEAKED THE BABY'S FEEDING. AFTER THE FEEDING WAS COMPLETE AND THE PUMP TURNED OFF, THE BABY WAS FUSSY AND ACTING HUNGRY. IT WAS THEN DISCOVERED HIS LINENS SOAKED IN FORMULA UNDER THE TUBING AND NG CONNECTION. SOME FORMULA WAS MANUALLY PUSHED THROUGH THE TUBING AND IT WAS ALL LEAKING OUT OF A CRACK AT THE HUB. THE BABY WAS RE-FED THROUGH NEW TUBING THAT WAS NOT CRACKED OR LEAKING (LOT# 20200227). SIX DAYS LATER. THE FEEDING TUBE (NEOCONNECT ENTERAL EXTENSION SET WITH ENFIT CONNECTOR LOT:20200110) LEAKED MEDOLAC FEED WHERE IT CONNECTS TO THE PATIENT'S NG TUBE WHEN BEING ADMINISTERED BY PUMP. THE HEALTH CARE PROVIDER CAUGHT THE LEAK EARLY SO ONLY A FEW ML WAS WASTED AND NEW TUBING WAS OBTAINED TO DELIVER THE REMAINDER OF THE PATIENT'S FEED.

    Description of Event or Problem · 1

    WE ARE REPORTING TWO FAILURES OF THE SAME PRODUCT THAT HAPPENED WITHIN 1 WEEK OF EACH OTHER: ON (B)(6) 2020: THE FEEDING TUBING WAS FOUND TO HAVE LEAKED THE BABY'S FEEDING. AFTER THE FEEDING WAS COMPLETE AND THE PUMP TURNED OFF, THE BABY WAS FUSSY AND ACTING HUNGRY. IT WAS THEN DISCOVERED HIS LINENS SOAKED IN FORMULA UNDER THE TUBING AND NG CONNECTION. SOME FORMULA WAS MANUALLY PUSHED THROUGH THE TUBING AND IT WAS ALL LEAKING OUT OF A CRACK AT THE HUB. THE BABY WAS RE-FED THROUGH NEW TUBING THAT WAS NOT CRACKED OR LEAKING (LOT# 20200227). ON (B)(6) 2020: THE FEEDING TUBE (NEOCONNECT ENTERAL EXTENSION SET WITH ENFIT CONNECTOR LOT:20200110) LEAKED MEDOLAC FEED WHERE IT CONNECTS TO THE PATIENT'S NG TUBE WHEN BEING ADMINISTERED BY PUMP. THE HEALTH CARE PROVIDER CAUGHT THE LEAK EARLY SO ONLY A FEW ML WAS WASTED AND NEW TUBING WAS OBTAINED TO DELIVER THE REMAINDER OF THE PATIENT'S FEED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1174992 NEOCONNECT ENTERAL EXTENSION SET TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT NEOMED, INC. PEXT-60NC 20200227 00817584012028

    Patients

    Seq Age Sex Outcome Treatment
    1