BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2230878 · Received September 1, 2011

    Report

    Report Number
    6000001-2011-21796
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    June 10, 2011
    Report Date
    June 14, 2011
    Manufacturer
    BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL SAMPLE FOR THIS REPORT WAS NOT RETURNED FOR EVALUATION; HOWEVER, FIVE SAMPLES WITH THE SAME REPORTED CONDITION AND LOT NUMBER WERE RECEIVED FROM THE FACILITY. A VISUAL EXAMINATION OF THE SAMPLES REVEALED HOLES IN THE PACKAGING. THE REPORTED CONDITION WAS CONFIRMED. ALTHOUGH THE CONDITION WAS CONFIRMED, THE ROOT CAUSE WAS NOT IDENTIFIED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. AS AN IMMEDIATE ACTION TO REMEDIATE THE ISSUE, A NEW DEFLATION SYSTEM WILL BE INSTALLED IN THE PACKAGING MACHINES. THIS EQUIPMENT WILL ALLOW THE REMOVAL OF EXCESS AIR INSIDE THE POUCHES TO AVOID PRESSURE ON THE SETS DURING PACKING. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) A LIGHT SENSITIVE DRUG SET IN WHICH THE PACKAGING WAS DAMAGED. ACCORDING TO THE REPORT, THE PAPER PRINT LABEL ON THE OVERPOUCH GOT DAMAGED EASILY WHEN TAKEN FROM THE CARTON. THE CONDITION WAS IDENTIFIED BEFORE PATIENT USE; THEREFORE, THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THIS IS REPORT 94 OF 162 OF THE SAME REPORTED PROBLEM FROM THIS FACILITY. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS 10I24V685M

    Patients

    Seq Age Sex Outcome Treatment
    1