BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 4163497 · Received October 10, 2014

    Report

    Report Number
    1416980-2014-35355
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 16, 2014
    Manufacturer
    BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ACTUAL DEVICE WAS NOT RETURNED FOR EVALUATION; HOWEVER, A RETAINED DEVICE WAS EVALUATED. THE ROTATING LUER LOCK OF THE RETAINED SAMPLE WAS VISUALLY INSPECTED; NO ISSUE WAS DETECTED AND THE RETAINED SET WAS CONFORMING AS PER PRODUCT SPECIFICATIONS. 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 PRIMARY CONTINU-FLO ADMINISTRATION SET HAD A ROTATING LUER THAT DID NOT MAKE A SECURE FIT. THIS RESULTED IN A LEAK OCCURRED DURING INFUSION OF AN UNKNOWN SOLUTION. THERE WAS NO REPORT OF 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
    640566 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS 13J21V083

    Patients

    Seq Age Sex Outcome Treatment
    1