BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 50ML LUER-LOK SYRINGE

    MDR report key: 8283849 · Received January 28, 2019

    Report

    Report Number
    3003152976-2019-00115
    Event Type
    Malfunction
    Date Received
    January 28, 2019
    Date of Event
    January 17, 2019
    Report Date
    March 19, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: ONE USED SAMPLE UNIT AND MULTIPLE PHOTOS WERE RECEIVED FOR EVALUATION. THROUGH VISUAL INSPECTION OF THE SAMPLES, A BROWN TINTED DRUG WAS OBSERVED WITHIN THE SYRINGE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO QUALITY ISSUES WERE FOUND DURING THE PRODUCTION OF LOT NUMBER 1810238 RELATED TO THIS INCIDENT. THERE HAVE BEEN NO CHANGES IN THE RAW MATERIAL OR THE WITHIN THE MANUFACTURING PROCESS THAT COULD OF CONTRIBUTED TO THE REPORTED ISSUE. BASED ON THE AVAILABLE INFORMATION, AN EXACT CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD PLASTIPAK¿ 50ML LUER-LOK SYRINGE WAS USED TO PREPARED A MIDAZOLAM SOLUTION, AND THE SOLUTION WAS BROWN.

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BD PLASTIPAK¿ 50ML LUER-LOK SYRINGE WAS USED TO PREPARED A MIDAZOLAM SOLUTION, AND THE SOLUTION WAS BROWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73476 BD PLASTIPAK 50ML LUER-LOK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1810238

    Patients

    Seq Age Sex Outcome Treatment
    1 Other