BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 4094050 · Received September 16, 2014

    Report

    Report Number
    1416980-2014-31625
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 22, 2014
    Manufacturer
    BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED; HOWEVER, A PHOTOGRAPH WAS PROVIDED FOR EVALUATION. PHOTOGRAPHIC INSPECTION DID NOT SHOW ANY DEFECTS RELATED TO THE REPORTED PROBLEM. THE REPORTED PROBLEM WAS NOT VERIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A VENTED PACLITAXEL SET LEAKED FROM THE BOTTOM OF ITS CHAMBER. THIS OCCURRED AFTER PATIENT INFUSION OF A CHEMOTHERAPEUTIC DRUG AND DURING FLUSHING WITH NORMAL SALINE. SPOTS OF NORMAL SALINE WERE OBSERVED ON THE FLOOR. THE REPORTER STATED THAT THE PURPOSE OF THE FLUSH WAS NOT TO REUSE THE DEVICE BUT TO DELIVER THE RESIDUAL CHEMOTHERAPEUTIC SOLUTION TO THE PATIENT. THE REPORTER DID NOT KNOW IF LEAKAGE OF THE CHEMOTHERAPEUTIC SOLUTION OCCURRED DURING THE INFUSION. 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
    570886 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS

    Patients

    Seq Age Sex Outcome Treatment
    1