BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3900549 · Received June 27, 2014

    Report

    Report Number
    1416980-2014-20697
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Report Date
    June 4, 2014
    Manufacturer
    BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS
    Product Code
    BRZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS REPORTED TO BE UNAVAILABLE FOR EVALUATION. A BATCH REVIEW WILL BE PERFORMED. IF ANY RELEVANT INFORMATION IS OBTAINED THAT IS RELATED TO THE REPORTED EVENT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED FOR EVALUATION, THEREFORE THE REPORTED CONDITION COULD NOT BE VERIFIED AND THE CAUSE COULD NOT BE IDENTIFIED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ADMINISTRATION SET FOR BLOOD AND BLOOD COMPONENTS LEAKED. THIS OCCURRED DURING PRIMING FOR A NEONATAL BLOOD TRANSFUSION, WHILE THE SET WAS CONNECTED TO A NON-BAXTER SYRINGE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377192 ACCESS SET, BLOOD TRANSFUSION BRZ BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS 13G05V036

    Patients

    Seq Age Sex Outcome Treatment
    1 BD PLASTIPACK 50ML LUER LOCK SYRINGE