BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2213060 · Received August 16, 2011

    Report

    Report Number
    6000001-2011-19068
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 26, 2011
    Manufacturer
    BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH THE SAMPLE WAS MADE AVAILABLE FOR INVESTIGATION, IT WAS INADVERTENTLY MISPLACED DURING SHIPPING OR RECEIVING. INVESTIGATION HAS BEEN INITIATED TO ADDRESS THIS ISSUE. IF THE SAMPLE BECOMES AVAILABLE FOR INVESTIGATION THE COMPLAINT FILE WILL BE REOPENED. A SAMPLE IS CURRENTLY NOT AVAILABLE FOR EVALUATION; THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND DURING THE MANUFACTURE OF THIS LOT. BAXTER FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE IS AVAILABLE FOR EVALUATION; HOWEVER, THE SAMPLE HAS NOT YET BEEN RECEIVED. ONCE THE SAMPLE IS RECEIVED AND EVALUATED A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER (B)(4) OF A PATIENT THAT WAS RECEIVING TREATMENT WITH DACARBAZINE USING A BAXTER LIGHT SENSITIVE DRUG SET . A LEAK WAS NOTICED FROM THE SET AND APPROXIMATELY 20MLS OF DACARBAZINE LEAKED ONTO THE FLOOR. THE PATIENT TREATMENT WAS STOPPED AND THE SET WAS CHANGED AND THE TREATMENT WAS CONTINUED. THE PATIENT WAS EXPOSED TO THE DACARBAZINE WHICH LEAKED ONTO THE FLOOR. IT WAS CONFIRMED THAT THERE WAS NO BAXTER DRUG INVOLVED DURING THIS INCIDENT. THERE WAS NO PATIENT INJURY INVOLVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS 10I24V685M

    Patients

    Seq Age Sex Outcome Treatment
    1 DACARBAZINE