BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 4840826 · Received June 12, 2015

    Report

    Report Number
    1416980-2015-24985
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Date of Event
    May 14, 2014
    Report Date
    May 18, 2015
    Manufacturer
    BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED LOT NUMBER OF 12L31V116 IS INVALID. THE DEVICE WAS NOT RETURNED AND THE REPORTED LOT NUMBER IS INVALID; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LIGHT SENSITIVE DRUG SET LEAKED FROM THE ¿TRANSPARENT¿ PORTION OF THE SET THAT WAS INSERTED INTO A COLLEAGUE PUMP. 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
    386500 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS 12L31V116

    Patients

    Seq Age Sex Outcome Treatment
    1 COLLEAGUE PUMP