BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAMPER-EVIDENT ORAL TIP CAP

    MDR report key: 5294212 · Received December 9, 2015

    Report

    Report Number
    MW5058480
    Event Type
    Malfunction
    Date Received
    December 9, 2015
    Date of Event
    December 9, 2015
    Report Date
    December 9, 2015
    Manufacturer
    BAXTER HEALTHCARE SA
    Product Code
    KYX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE NURSE WAS GIVING THE BABY HER VITAMIN D 400 UNITS/1 ML VIA A NASOGASTRIC TUBE, BUT COULD NOT PUSH THE MEDICATION OUT. SHE SHOWED ME THE SYRINGE AND I SAW THAT A PIECE OF THE CAP BROKE OFF AND WAS STUCK IN THE ORAL SYRINGE. BAXTER HEALTHCARE SA EXACTAMED ORAL DISPENSERS. (B)(4), LOT 1083251.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    813348 TAMPER-EVIDENT ORAL TIP CAP TAMPER-EVIDENT ORAL TIP CAP KYX BAXTER HEALTHCARE SA H93852300 NS-647

    Patients

    Seq Age Sex Outcome Treatment
    1 42 DA