BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5 MM ASPIRATION NEEDLE

    MDR report key: 5719687 · Received June 13, 2016

    Report

    Report Number
    5719687
    Event Type
    Malfunction
    Date Received
    June 13, 2016
    Date of Event
    May 25, 2016
    Report Date
    June 9, 2016
    Manufacturer
    PURPLE SURGICAL INTERNATIONAL LIMITED
    Product Code
    GAA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PRODUCT STERILE PACKAGING INTEGRITY QUESTIONED. "BUBBLE" NOTED ON PRODUCT PACKAGE STERILIZATION SEAL LINE ON MULTIPLE PACKAGES. DISPOSABLE PRODUCT BROUGHT IN FOR TRIAL TO REPLACE REUSABLE ASPIRATION NEEDLE. NO PATIENT EXPOSED. PRODUCT INFO: PURPLE SURGICAL 5MM ASPIRATION NEEDLE PS3895 LOT#0913059.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375886 5 MM ASPIRATION NEEDLE NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA PURPLE SURGICAL INTERNATIONAL LIMITED 5 MM 0913059

    Patients

    Seq Age Sex Outcome Treatment
    1