BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEOCONNECT ENTERAL EXTENSION SET

    MDR report key: 10275436 · Received July 15, 2020

    Report

    Report Number
    10275436
    Event Type
    Malfunction
    Date Received
    July 15, 2020
    Date of Event
    May 18, 2020
    Report Date
    July 10, 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 · 1

    A TOTAL OF 22 DEFECTIVE NEOCONNECT 60" (152 CM) ENFIT EXTENSION SETS (PEXT-60NC) WERE FOUND BETWEEN MAY 18TH AND JUNE 15TH, 2020. THE TUBING SETS WERE FROM 4 DIFFERENT LOT NUMBERS, BUT THE SAME DI/PRODUCT/REFERENCE #S. THE DEFECTIVE LOTS WERE AS FOLLOWS: 20191126, 20191218, 20191230, AND 20200110. THE CAREGIVERS FOUND THE ENFIT FEEDING EXTENSION LEAKING AT THE PATIENT CONNECTION. ALL HAVE BEEN CHECKED TO MAKE SURE THEY WERE SECURED APPROPRIATELY WITH NO "TILTING" OR MISCONNECTION NOTED. ALSO THAT THEY WERE NOT "TOO TIGHT" OR "LOOSE". SOME HAVE BEEN NOTED TO BE CRACKED AT PATIENT SIDE SECUREMENT. ONCE WE HAD 2 EXTENSIONS THAT WERE COMPROMISED, WE IMMEDIATELY NOTIFIED OUR NURSING STAFF TO WATCH FOR OTHERS. BECAUSE OUR STAFF WAS AWARE, THEY HAVE BEEN ABLE TO CATCH THE LEAKS EARLY ON SO INFANTS RECEIVE THEIR FULL CALORIES AS ORDERED. THEY HAVE WORKED WITH MATERIALS TO PULL THOSE LOT NUMBERS AS DEFECTIVE BATCHES HAVE BEEN FOUND. ONLY FOUR PATIENTS ARE INCLUDED IN THIS REPORTS ALTHOUGH THERE WERE MORE AFFECTED. BREAKDOWN OF LOT #'S: 20191126 - 8 TOTAL. 20191218 - 3 TOTAL. 20191230 - 3 TOTAL. 20200110 - 1 TOTAL. UNKNOWN - 7 TOTAL (PACKAGING NOT SAVED BUT CONNECTION/TUBING WAS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744523 NEOCONNECT ENTERAL EXTENSION SET TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT NEOMED, INC. PEXT-60NC 20191126 00817584012028

    Patients

    Seq Age Sex Outcome Treatment
    1 35 DA