BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2880028 · Received December 19, 2012

    Report

    Report Number
    1416980-2012-07712
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 27, 2012
    Manufacturer
    BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS
    Product Code
    FMG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CUSTOMER REPORTED CONDITION WAS CONFIRMED DURING SAMPLE EVALUATION. ONE ACTUAL DEFECTIVE SAMPLE AND SEVENTY-NINE COMPANION SAMPLES WERE RETURNED AT THE PLANT FOR EVALUATION. THE RETURNED UNITS WERE VISUALLY CHECKED, NO ISSUE WAS DETECTED. THE RETURNED SAMPLES WERE PUSH PULL TESTED IN THE LABORATORY AND THE TRACTION TESTS CONFIRMED THAT FOUR SETS SHOWED TUBE DISCONNECTED FROM THE CHAMBER. NO FURTHER TESTING WAS PERFORMED. THE ASSIGNABLE ROOT CAUSE OF THE REPORTED CONDITION IS UNKNOWN. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THIS ISSUE IS BEING INVESTIGATED THROUGH CAPA. SHOULD ADDITIONAL RELEVANT INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A PHARMACIST OF THE FACILITY REPORTED TO BAXTER (B)(4) OF A DEHP FREE SOLUTION ADMINISTRATION SET WITH INJECTION SITE AND 3 WAY STOPCOCK IN WHICH OPERATOR FOUND THE TUBING DISCONNECTED FROM CHAMBER. THE REPORTED CONDITION OCCURRED DURING INFUSION. A PATIENT WAS INVOLVED, BUT THERE IS NO REPORT OF PATIENT/USER INJURY OR MEDICAL INTERVENTION WAS NEEDED IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS STOPCOCK, I.V. SET FMG BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS 11J14V045

    Patients

    Seq Age Sex Outcome Treatment
    1