BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2870872 · Received December 12, 2012

    Report

    Report Number
    1416980-2012-07178
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    October 17, 2012
    Report Date
    November 22, 2012
    Manufacturer
    BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED TO BAXTER (B)(4) OF A CONTROL A-FLO EXTENSION SET IN WHICH THE OPERATOR COULD NOT ADJUST THE FLOW REGULATOR.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CUSTOMER REPORTED CONDITION WASN'T CONFIRMED DURING SAMPLE EVALUATION. THE ACTUAL DEFECTIVE SAMPLE WAS AVAILABLE FOR EVALUATION AT THE PLANT. NO DEFECT WAS OBSERVED DURING VISUAL INSPECTION. THE RETURNED UNIT WAS ALSO TESTED FOR GRAVITY AND FOR FLOW RATE IN THE LABORATORY, NO ISSUE WAS DETECTED. BOTH TESTS WERE CONFORMING AND THE LIQUID FLOWS CORRECTLY THROUGH THE TUBING. NO OTHER TEST WAS PERFORMED. THE RETURNED SET WAS WORKING WITHIN SPECIFICATION. ADDITIONAL INFORMATION: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BAXTER CHINA OF A CONTROL A-FLO EXTENSION SET IN WHICH OPERATOR COULDN'T ADJUST ROLLER CLAMP. THE REPORTED CONDITION OCCURRED BEFORE PATIENT USE. THERE IS NO REPORT OF PATIENT INVOLVEMENT, INJURY/ADVERSE EVENTS, OR MEDICAL INTERVENTION IN ASSOCIATION WITH THIS EVENT. 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 12A10V010

    Patients

    Seq Age Sex Outcome Treatment
    1