BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2870924 · Received December 12, 2012

    Report

    Report Number
    1416980-2012-07183
    Event Type
    Malfunction
    Date Received
    December 12, 2012
    Date of Event
    November 22, 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
    BR
    Reporter Occupation
    OTHER

    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. THE DEFECTIVE SAMPLE WAS RETURNED AT THE PLANT FOR EVALUATION. THE UNIT WAS VISUALLY CHECKED AND THE SAMPLE'S ANALYSIS SHOWED SMALL BROWN TRACES OF BURNED PLASTIC FIXED AND MELTED INSIDE THE PVC (POLYVINYL CHLORIDE) DRIP CHAMBER COMPOSITION, OUTSIDE FLUID PATH. NO OTHER TEST WAS PERFORMED. THE ASSIGNABLE ROOT CAUSE OF THE REPORTED CONDITION IS DUE TO DEFECTIVE PART, DRIP CHAMBER, RECEIVED FROM THE SUPPLIER. A NOTIFICATION HAS BEEN SENT TO THE SUPPLIER TO ENSURE AWARENESS. 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 INFORMATION BE RECEIVED, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TO BAXTER (B)(4) OF A VENTED PACLITAXEL SET IN WHICH THE OPERATOR OBSERVED PARTICULATE MATTER INSIDE THE DRIP CHAMBER. 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 11F26V747

    Patients

    Seq Age Sex Outcome Treatment
    1