BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTRISTAR JEJUNAL FEEDING/GASTRIC DECOMP. TUBE

    MDR report key: 111107 · Received August 7, 1997

    Report

    Report Number
    2242547-1997-00015
    Event Type
    Injury
    Date Received
    August 7, 1997
    Report Date
    July 8, 1997
    Manufacturer
    BIOSEARCH MEDICAL PRODUCTS, INC.
    Product Code
    KNT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT SAMPLE WAS RETURNED AND EVALUATED. LOT SPECIFICATION INFO WAS NOT AVAILABLE. SEPARATION APPEARED TO BE DUE TO INSUFFICIENT ADHESION AT THE JUNCTION OF THE WEIGHTED TIP. THIS PRODUCT WAS PRODUCED AT OUR VENDOR FACILITY, WHICH HAS SUBSEQUENTLY ESSENTIALLY CEASED OPERATIONS. NO INFO WAS FORTHCOMING FROM THE VENDOR. CO IS UNABLE TO INVESTIGATE THE PROBLEM FURTHER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE WEIGHT (ED TIP) OF THE TUBE IS LODGED IN THE MIDDLE OF THE BABY'S INTESTINE. LATER, THE WEIGHTED TIP WAS REMOVED FROM THE INTESTINE ENDOSCOPICALLY. NO OTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTRISTAR JEJUNAL FEEDING/GASTRIC DECOMP. TUBE FEEDING TUBE KNT BIOSEARCH MEDICAL PRODUCTS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention