BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TIP CAPS,LUER SLIP,STER,YEL, 1

    MDR report key: 6185602 · Received December 19, 2016

    Report

    Report Number
    1416980-2016-18512
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Date of Event
    November 22, 2016
    Report Date
    January 26, 2017
    Manufacturer
    BAXTER HEALTHCARE - ENGLEWOOD
    Product Code
    KYX
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE UNIQUE DEVICE IDENTIFIER FOR THIS PRODUCT IS (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION IDENTIFIED A DARK SPOT ON THE TIP COVER. MICROSCOPIC EXAMINATION REVEALED THAT THE SPOT APPEARED TO BE EMBEDDED IN THE TIP COVER AND WAS LARGER THAN 0.6 SQUARE MILLIMETERS. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE REPORTED CONDITION COULD NOT BE DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DISCPAC SELF-RIGHTING LUER SLIP TIP CAP WAS ¿CONTAMINATED.¿ THIS WAS OBSERVED AFTER THE PACKAGING WAS OPENED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    835847 TIP CAPS,LUER SLIP,STER,YEL, 1 DISPENSER, LIQUID MEDICATION KYX BAXTER HEALTHCARE - ENGLEWOOD NA 1167867

    Patients

    Seq Age Sex Outcome Treatment
    1