BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10 ML SPRAYSHIELD KIT AND AIR ASSISTED SPRAYER STERILE SINGLE USE 1

    MDR report key: 4096112 · Received August 29, 2014

    Report

    Report Number
    3003418325-2014-00003
    Event Type
    Malfunction
    Date Received
    August 29, 2014
    Report Date
    August 7, 2014
    Manufacturer
    INTEGRA LIFESCIENCES HOLDING CORPORATION
    Product Code
    NQR
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    A 10 ML SPRAYSHIELD KIT AND AIR ASSISTED SPRAYER STERILE SINGLE USE WHICH HAD AN EXPIRATION DATE OF (B)(6) 2014, WAS USED ON A PT ON (B)(6), 2014. NOTE: THIS WAS SUPPLIED TO THE HOSPITAL BY THE PREVIOUS DISTRIBUTOR IN (B)(4) AND WAS NOT SHIPPED FROM INTEGRA LIFE SCIENCES-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529117 10 ML SPRAYSHIELD KIT AND AIR ASSISTED SPRAYER STERILE SINGLE USE 1 SPRAYSHIELD NQR INTEGRA LIFESCIENCES HOLDING CORPORATION N3G0239X

    Patients

    Seq Age Sex Outcome Treatment
    1