BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADMIN.SET FOR BLOOD/BLOOD/DERIVATIVES

    MDR report key: 2001265 · Received February 25, 2011

    Report

    Report Number
    6000001-2011-01339
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 9, 2011
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    BRZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL EXAMINATION OF THE SAMPLE CONFIRMED THE REPORTED CONDITION OF CUT AND SQUEEZED TUBING. THE ROOT CAUSE OF THIS CONDITION WAS ATTRIBUTED TO THE SET CHANGING ORIENTATION DURING PACKAGING IN THE PRE-FORMED PLASTIC POUCHES (FORMED BY THE PACKAGING MACHINE). A PART OF THE SET WAS PROTRUDING OUT OF THE PLASTIC POUCH AND WHEN THE PACKAGING MACHINE INDEXED TO SEAL THE LOADED POUCH, THE PROTRUDING PART WAS CAUGHT IN THE SEAL BETWEEN THE PLASTIC POUCH AND THE PAPER. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). ONE ACTUAL UNIT WAS RECEIVED FOR EVALUATION; HOWEVER, THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF EVALUATION OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE. 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)(6) A BLOOD TRANSFUSION SET WITH NON-VENTED DOUBLE DRIP CHAMBER AND 200M FILTER AND ROTARY LUER LOCK ADAPTER IN WHICH THE TUBING WAS CUT. ACCORDING TO THE REPORT, AFTER TAKING THE PACKAGE OUT OF THE BOX THE TUBING WAS NOTICED TO BE CUT/SQUEEZED MAKING THE PRODUCT UNUSABLE. THE CONDITION WAS IDENTIFIED BEFORE PATIENT USE; THEREFORE, THER WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADMIN.SET FOR BLOOD/BLOOD/DERIVATIVES SET, BLOOD TRANSFUSION BRZ BAXTER HEALTHCARE - MALTA 10F30V803M

    Patients

    Seq Age Sex Outcome Treatment
    1