BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OH PACK

    MDR report key: 4090117 · Received August 18, 2014

    Report

    Report Number
    2248146-2014-00338
    Event Type
    Malfunction
    Date Received
    August 18, 2014
    Date of Event
    August 1, 2012
    Report Date
    August 1, 2012
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. IF THE UNSEALED HEADER BAG DOES NOT COMPROMISE THE STERILITY OR FUNCTIONALITY OF THE KIT BUT CREATES A KIT THAT DOES NOT MEET CUSTOMER EXPECTATIONS. THE TYVEK LID STOCK CREATES THE "STERILE BARRIER" FOR THE CONTENTS OF THE TRAY WHILE THE HEADER BAG PACKAGING IS INCLUDED AT THE REQUEST OF THE CUSTOMER. MOVING FORWARD, ALL COMPLAINTS RELATED TO LOT 14104-04 WILL BE MONITORED TO DETERMINE IF THE UNSEALED HEADER BAG IS A REPEATED COMPLAINT OR IF IT IS AN ISOLATED ISSUE. IN ADDITION, ALL MCP ASSEMBLY OPERATORS WILL BE RE-TRAINED TO THE APPROPRIATE PROCEDURE RELATED TO THE UNSEALED HEADER BAG. (B)(4).

    Description of Event or Problem · 1

    THE STERILE BAG CONTAINING LINES 13-16 WAS NOT SEALED, STERILE, BUT NOT SEALED. THE TYVEK PORTION WAS SEALED, THE PLASTIC BAG WAS NOT SEALED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496395 OH PACK CARDIOPULMONARY DEVICE DWE DATASCOPE CORP. BEQ-TOP 40201 14104-04

    Patients

    Seq Age Sex Outcome Treatment
    1