BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3760989 · Received April 21, 2014

    Report

    Report Number
    1416980-2014-12771
    Event Type
    Malfunction
    Date Received
    April 21, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 27, 2014
    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). A BATCH REVIEW WILL BE PERFORMED. IF THE SAMPLE BECOMES AVAILABLE FOR EVALUATION OR ANY RELEVANT INFORMATION IS OBTAINED THAT IS RELATED TO THE REPORTED EVENT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, ANALYSIS OF THE ACTUAL SAMPLE COULD NOT BE PERFORMED. HOWEVER, A RETAINED SAMPLE WAS EVALUATED. VISUAL INSPECTION OF THE RETAINED SAMPLE DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. FUNCTIONAL LEAK TESTING WAS PERFORMED ON THE RETAINED SAMPLE, AND NO LEAKS WERE OBSERVED. 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 A LIGHT SENSITIVE DRUG SET EXPERIENCED A LEAK. THE LOCATION IS UNKNOWN. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240550 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS 13G25V116

    Patients

    Seq Age Sex Outcome Treatment
    1