BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2212027 · Received August 15, 2011

    Report

    Report Number
    6000001-2011-18898
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    March 12, 2011
    Report Date
    March 18, 2011
    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). THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT HAVE 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. ONE USED SAMPLE WAS RECEIVED AT THE PLANT FOR EVALUATION. THE REPORTED CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE CAN NOT BE DETERMINED. A BATCH REVIEW CANNOT BE PERFORMED SINCE A LOT NUMBER WAS NOT PROVIDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT ONE (1) BURETROL IV SOLUTION ADMINISTRATION SET FOUND LEAKING SOLUTION INTO BURETROL CHAMBER DESPITE THE ROLLER CLAMP BEING SHUT DURING PATIENT USE. THERE WAS PATIENT INVOLVEMENT HOWEVER NO INJURY REPORTED ASSOCIATED TO THIS ISSUE.

    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

    Patients

    Seq Age Sex Outcome Treatment
    1