BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CUSTOMED STERILE CONVENIENCE PACKS SURGICAL

    MDR report key: 4146661 · Received September 5, 2014

    Report

    Report Number
    2648727-2014-00001
    Event Type
    Malfunction
    Date Received
    September 5, 2014
    Date of Event
    August 29, 2014
    Report Date
    September 5, 2014
    Manufacturer
    CUSTOMED, INC.
    Product Code
    KDD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION PERFORMED THROUGH A RISK ASSESSMENT IDENTIFIED AN ADVERSE TREND REGARDING PACKAGING AND SHIPPING CONTAINERS IN 2014. AS A CONSEQUENCE IT WAS CONDITIONED THE RELEASE OF THE PRODUCTS TO THE FOLLOWING PREVENTIVE REQUIREMENTS: BATCH RECORD IN-PROCESS REQUIREMENTS. VISUAL INSPECTION POST-STERILIZATION WITH ZERO DEFECTS 100%. ACCEPTABLE VISUAL INSPECTION AFTER SIMULATED SHIPPING CONDITIONS. ACCEPTABLE INTERNAL PRESSURIZATION RESISTANCE TEST (POST STERILIZATION) OF UNRESTRAINED PACKAGES (BURST TEST) OF PRODUCTS. ACCEPTABLE BUBBLE EMISSION TEST TO PRODUCTS (EXTERNAL LABORATORY). SHIPPING REPORT REGARDING MATERIAL RELEASED WILL BE CONFIRMED BY QA PERSONNEL BEFORE TRANSFER OF PRODUCTS TO DISTRIBUTION CENTERS. MEDWATCH FORM FDA 3500A WAS SUBMITTED BECAUSE THE BUBBLE EMISSION LEAK TEST FAIL COMPROMISING THE STERILITY OF CONVENIENCE PACKS FOR SURGICAL USE PRODUCED AND DISTRIBUTED BY CUSTOMED INC. (B)(6) HOSPITAL, INC. AND CUSTOMED USA INC.

    Description of Event or Problem · 1

    BUBBLE EMISSION LEAK TEST FAIL COMPROMISING THE STERILITY OF PRODUCTS SHIPPED BY AIR PRODUCED BY CUSTOMED INC. AND DISTRIBUTED BY PR HOSPITAL INC. AND CUSTOMED USA INC. THE PRODUCT PACKAGE INTEGRITY FOR STERILITY IS CONSIDERED A PATIENT HEALTH HAZARD. RESULTS OF THE BUBBLE EMISSION LEAK TEST GLP REPORT ARE ATTACHED TO THIS DOCUMENT. THIS PRODUCT TEST WAS PART OF THE RISK ASSESSMENT OF CAPA (B)(4) OPENED AS A RESPONSE TO THE FDA 483 OBSERVATIONS FROM (B)(6) 2014. CUSTOMED PRODUCT CATALOGS THAT ARE SUBJECTED TO INVESTIGATION DUE TO THIS EVENT ARE LISTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    545335 CUSTOMED STERILE CONVENIENCE PACKS SURGICAL NONE KDD CUSTOMED, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R| S