BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2983657 · Received February 28, 2013

    Report

    Report Number
    1416980-2013-04986
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AVAILABLE SAMPLE HAS BEEN REQUESTED BUT NOT YET RECEIVED. IF ADDITIONAL RELEVANT INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE CONDITION COULD NOT BE CONFIRMED OR DUPLICATED AND THE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SYRINGE ADAPTOR SET HAD A DAMAGED INJECTION SITE; THIS WAS FOUND BEFORE USE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, PATIENT 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
    86104 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS 12E29V415

    Patients

    Seq Age Sex Outcome Treatment
    1