BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2880475 · Received December 19, 2012

    Report

    Report Number
    1416980-2012-07770
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    December 6, 2012
    Report Date
    December 6, 2012
    Manufacturer
    BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS
    Product Code
    FPA
    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). 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. EVALUATION SUMMARY: THE CUSTOMER REPORTED CONDITION WAS CONFIRMED DURING SAMPLE EVALUATION. ONE ACTUAL DEFECTIVE SAMPLE WAS RETURNED AT THE PLANT FOR EVALUATION. THE UNIT WAS VISUALLY CHECKED .THE VISUAL INSPECTION REVEALED THAT THE END OF THE SPIKE SHOWED INADEQUATE MOLDING IN THE RAW MATERIAL PART. NO FURTHER TESTING WAS PERFORMED. THE ROOT CAUSE OF THE REPORTED CONDITION IS UNKNOWN.

    Description of Event or Problem · 1

    A PHARMACIST OF THE FACILITY REPORTED TO BAXTER (B)(4) OF A SOLUTION ADMINISTRATION SET IN WHICH OPERATOR FOUND A DEFORMED SPIKE. 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 12I12V673

    Patients

    Seq Age Sex Outcome Treatment
    1