BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK SYRINGE

    MDR report key: 8749211 · Received July 1, 2019

    Report

    Report Number
    3003152976-2019-00434
    Event Type
    Malfunction
    Date Received
    July 1, 2019
    Date of Event
    June 14, 2019
    Report Date
    August 8, 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
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE PHOTO SAMPLE WAS PROVIDED FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A MOLDING DEFECT WAS OBSERVED ON THE 2ML MARKING OF THE SYRINGE SCALE. A DEVICE HISTORY WAS PERFORMED AND FOUND NO NO-CONFORMANCES RELATED TO THE REPORTED ISSUE DURING PRODUCTION OF BATCH 1811245. PRODUCT UNDERGOES VISUAL AND FUNCTIONAL INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS ACCORDING TO PROCEDURE. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, IT WAS DETERMINED THIS INCIDENT OCCURRED DUE TO A FAILURE IN THE INJECTION MACHINE DURING THE MOLDING PROCESS. THE DEFECTIVE OBSERVED IS UNFILLED MATERIAL LIKELY DUE TO THE POLYPROPYLENE NOT CORRECTLY FILLING IN THE MOLD AND RESULTING IN AN INCOMPLETE BARREL. MANUFACTURING PERSONNEL HAVE BEEN MADE AWARE OF YOUR EXPERIENCE TO INCREASE AWARENESS OF THIS MATTER. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PLASTIPAK¿ SYRINGE HAD A HOLE IN THE SIDE OF THE SYRINGE. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAVE BEEN ASKED TO REPORT A DEFECTIVE PRODUCT ON BEHALF OF OUR PRODUCTION TEAM. A BD 20ML SYRINGE BATCH NUMBER 1811245 EXPIRY 10/2023 HAS A HOLE IN THE SIDE OF THE SYRINGE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PLASTIPAK¿ SYRINGE HAD A HOLE IN THE SIDE OF THE SYRINGE. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I HAVE BEEN ASKED TO REPORT A DEFECTIVE PRODUCT ON BEHALF OF OUR PRODUCTION TEAM. A BD 20ML SYRINGE BATCH NUMBER 1811245 EXPIRY 10/2023 HAS A HOLE IN THE SIDE OF THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542861 BD PLASTIPAK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1811245

    Patients

    Seq Age Sex Outcome Treatment
    1 Other