BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLO-GARD IV SOLUTION ADMIN SET

    MDR report key: 1912005 · Received December 1, 2010

    Report

    Report Number
    6000001-2010-05354
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 10, 2010
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION. SAMPLE RECEIVED FOR EVALUATION ON (B)(6) 2010. AN ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION REVEALED THAT THE TUBE HAD A CUT. FURTHERMORE, A MISSING SEAL WAS NOTICED ON THE POUCH HENCE REPORTED PROBLEM WAS CONFIRMED. 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. BAXTER IS CURRENTLY INVESTIGATING THIS ISSUE TO EVALUATE THE POSSIBILITY OF TAKING FURTHER ACTIONS TO MINIMIZE/ELIMINATE THIS NON-CONFORMANCE. BAXTER SHALL KEEP MONITORING THESE EVENTS DURING QUALITY REVIEWS. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) OF A FLO-GARD IV SOLUTION ADMINISTRATION SET IN WHICH THE TUBING ON THE SET IS MOLDED TOGETHER. THE CONDITION WAS DISCOVERED BEFORE USE. THERE 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 FLO-GARD IV SOLUTION ADMIN SET SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - MALTA 10G25V150D

    Patients

    Seq Age Sex Outcome Treatment
    1