BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TAMPER-EVIDENT ORAL TIP CAP

    MDR report key: 845749 · Received April 5, 2007

    Report

    Report Number
    845749
    Event Type
    Malfunction
    Date Received
    April 5, 2007
    Date of Event
    March 20, 2007
    Report Date
    April 5, 2007
    Manufacturer
    BAXA CORPORATION
    Product Code
    KYX
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US

    Narratives

    Description of Event or Problem · 1

    RED TAMPER-EVIDENT ORAL TIP CAP WAS REMOVED FROM SYRINGE IN ORDER TO ADMINISTER MEDICATION VIA NG TUBE. WHEN CAP WAS PULLED OFF, STAFF NOTICED A PORTION OF THE CAP BROKE OFF IN THE SYRINGE. NO PATIENT HARM OCCURRED AND THE SYRINGE WAS SENT BACK TO THE PHARMACY, HOWEVER THE PRODUCT WAS NOT RETAINED. PHARMACY WAS ONLY ABLE TO DUPLICATE THE PROBLEM IF THE CAP WAS PULLED OFF AT AN ANGLE RATHER THAN STRAIGHT UP. THE MANUFACTURER HAS BEEN CONTACTED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TAMPER-EVIDENT ORAL TIP CAP SYRINGE CAP KYX BAXA CORPORATION * *

    Patients

    Seq Age Sex Outcome Treatment
    1 2 MO