BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2872550 · Received December 13, 2012

    Report

    Report Number
    1416980-2012-07260
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    July 2, 2012
    Report Date
    July 3, 2012
    Manufacturer
    BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ACTUAL SAMPLE WAS NOT RECEIVED HOWEVER, SAMPLE PICTURES WERE AVAILABLE FOR EVALUATION. PHOTOGRAPHIC INSPECTION REVEALED A DISCONNECTION AT THE LEVEL OF THE JUNCTION TUBE AND THE SPIKE. A RETAINED SAMPLE WAS TESTED AND THE DIMENSIONS OF BOTH PARTS (TUBE & SPIKE) WERE CONFORMING AS PER PRODUCT SPECIFICATIONS THE REPORTED CONDITION WAS CONFIRMED. THE ROOT CAUSE WAS NOT DETERMINED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER (B)(4) OF A BALL VALVE BURETROL I.V. SOL.ADMIN.SET IN WHICH THE SET SHOWED A DETACHMENT BETWEEN THE SPIKE AND TUBING. THE EVENT OCCURRED BEFORE 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 11L08V700

    Patients

    Seq Age Sex Outcome Treatment
    1