BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3973795 · Received August 1, 2014

    Report

    Report Number
    1416980-2014-25124
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 8, 2014
    Report Date
    July 9, 2014
    Manufacturer
    BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT AFTER THE CHEMOTHERAPY AGENT CAME IN CONTACT WITH THE PATIENT THE AFFECTED AREA WAS RINSED WITH A DECONTAMINATION WASHING OF AMUCHINA (SODIUM IPOCHLORIDE). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS RECEIVED FOR EVALUATION. DURING VISUAL INSPECTION, THE TUBING WAS OBSERVED TO BE DISCONNECTED FROM THE MILLIPORE FILTER. THE REPORTED PROBLEM WAS VERIFIED. THE CAUSE OF THE PROBLEM WAS DUE TO A MANUFACTURING ISSUE. A CAPA HAS BEEN OPENED FOR THIS ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MIRAFILTER ADMINISTRATION SET TUBING DISCONNECTED FROM THE DRIP CHAMBER. THIS OCCURRED DURING INFUSION OF PACLITAXEL. AFTER THE DISCONNECTION, THE DRUG SOLUTION DRIPPED ON THE PATIENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450273 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS 14A30V092

    Patients

    Seq Age Sex Outcome Treatment
    1 TAXOL (PACLITAXEL)