BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVT DISPOSABLE

    MDR report key: 2854894 · Received December 3, 2012

    Report

    Report Number
    1416980-2012-06321
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 9, 2012
    Manufacturer
    BAXTER HEALTHCARE - MALTA
    Product Code
    LHI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CUSTOMER REPORTED CONDITION OF "A VIALMATE IN WHICH A PIECE HAS BEEN CUT OUT FROM THE MEMBRANE AND IS NOW IN THE SOLUTION" WAS CONFIRMED DURING SAMPLE EVALUATION. AN ACTUAL SAMPLE WAS AVAILABLE AT THE PLANT FOR EVALUATION. THE VIALMATE WAS ATTACHED WITH A VIAL AND A VIAFLO BAG AND THE VIALMATE WAS UNLOCKED. VISUAL INSPECTION REVEALED A TINY PART OF THE VIAL'S RUBBER IN THE VIAL. THE VIALMATE WAS ACTIVATED WITH A NEW VIAL. NO DAMAGE WAS OBSERVED ON THE RUBBER AND NO PARTICLES WERE VISIBLE IN THE VIAL. THE VIALMATE WAS DISMANTLED TO BE FURTHER INVESTIGATED AND SHOWED NO NON-CONFORMITIES. INSPECTION ON THE VIAL REVEALED THAT THE RUBBER HAD BEEN PIERCED MORE THAN ONCE, THUS DETACHING PART OF THE RUBBER. REPEATED COUPLING OF THE VIALMATE TO THE VIAL WAS CLEARLY VISIBLE. THE ASSIGNABLE ROOT CAUSE OF THE REPORTED CONDITION IS USER ERROR. CORRECTION: A BATCH REVIEW WAS PERFORMED ON TWO POTENTIAL LOT NUMBERS PROVIDED BY THE CUSTOMER (12D18V184 AND 12G27V182). THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. ADDITIONAL INFORMATION: A LABELING REVIEW WAS PERFORMED AND THE INSTRUCTIONS ARE PRINTED ON EACH INDIVIDUAL PACKAGING ARE AVAILABLE TO THE USER AND ARE ACCURATE AND SUFFICIENT IN RELATION TO THE PREVENTION OF THE SUSPECTED USER ERROR IN THIS REPORT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER. A BATCH REVIEW CANNOT BE PERFORMED SINCE THERE WAS NO LOT NUMBER PROVIDED. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BAXTER (B)(4) OF A VIALMATE IN WHICH A PIECE HAS BEEN CUT OUT FROM THE MEMBRANE AND IS NOW IN THE SOLUTION. THE REPORTED CONDITION OCCURRED BEFORE PATIENT USE. THERE IS NO REPORT OF PATIENT INVOLVEMENT, INJURY/ADVERSE EVENTS, OR MEDICAL INTERVENTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVT DISPOSABLE SET, I.V. FLUID TRANSFER LHI BAXTER HEALTHCARE - MALTA

    Patients

    Seq Age Sex Outcome Treatment
    1