BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK LUER-LOK 30 ML SYRINGE

    MDR report key: 8412973 · Received March 12, 2019

    Report

    Report Number
    3003152976-2019-00201
    Event Type
    Malfunction
    Date Received
    March 12, 2019
    Date of Event
    February 21, 2019
    Report Date
    March 14, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903012299
    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

    H.6. INVESTIGATION: ONE PHOTO SAMPLE WAS PROVIDED TO OUR QUALITY ENGINEER FOR REVIEW. THROUGH VISUAL INSPECTION, TWO BROWN SPOTS WERE OBSERVED WITHIN THE SYRINGE. THE SPOTS WERE DETERMINED TO BE COMPOSED OF BURNT POLYPROPYLENE FROM THE MOLDING PROCESS. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOTS 1802267 AND 1803271, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THE REPORTED ISSUE WERE IDENTIFIED DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD PLASTIPAK¿ LUER-LOK¿ 30 ML SYRINGE HAD 2 SPOTS IN THE SYRINGE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1802267; MEDICAL DEVICE EXPIRATION DATE: 2023-01-31; DEVICE MANUFACTURE DATE: 2018-02-20; MEDICAL DEVICE LOT #: 1803271; MEDICAL DEVICE EXPIRATION DATE: 2023-02-28; DEVICE MANUFACTURE DATE: 2018-03-27. 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¿ LUER-LOK¿ 30 ML SYRINGE HAD 2 SPOTS IN THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203999 BD PLASTIPAK LUER-LOK 30 ML SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. SEE H.10 00382903012299

    Patients

    Seq Age Sex Outcome Treatment
    1 Other