BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK SYRINGE

    MDR report key: 8658387 · Received May 31, 2019

    Report

    Report Number
    3003152976-2019-00368
    Event Type
    Malfunction
    Date Received
    May 31, 2019
    Date of Event
    May 1, 2019
    Report Date
    June 14, 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: TWO PHOTOS WERE PROVIDED TO OUR QUALITY ENGINEER FOR INVESTIGATION. THROUGH VISUAL INSPECTION, THE SYRINGE BARREL WAS OBSERVED TO BE DAMAGED BETWEEN THE 15ML AND 20ML MARKING. THE BARREL IS DENTED IN THIS AREA AND THE STOPPER RIBS BECOME DISTORTED WHEN MOVED ACROSS THIS POINT, CAUSING A LEAK AS A RESULT. A DEVICE HISTORY WAS PERFORMED AND FOUND NO NO-CONFORMANCES RELATED TO THE REPORTED ISSUE DURING PRODUCTION OF BATCH 1902237. PRODUCT UNDERGOES VISUAL AND FUNCTIONAL TESTING THROUGHOUT THE MANUFACTURING PROCESS ACCORDING TO PROCEDURE. THE DAMAGE NOTED IN THE PHOTO IS CONSISTENT WITH MARKINGS FROM THE TRANSFERENCE WHEELS OF THE ASSEMBLY MACHINE. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, WE DETERMINED THIS INCIDENT OCCURRED DUE TO THE BARREL JAMMING IN THE TRANSFERENCE WHEELS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PLASTIPAK¿ SYRINGE LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TCI ANESTHETIC USING STANDARD PK PUMPS. SUDDEN ONSET OF LEAKAGE OF PROPOFOL BACKWARDS THROUGH SYRINGE PLUNGER AND ONTO FLOOR. CRACK IN OUTER SYRINGE, POSSIBLE DEFECT ALSO IN PLUNGER. I HAVE NOT SEEN THIS PROBLEM WITH A TCI SYRINGE PREVIOUSLY. NO INJURY TO PATIENT OR HEALTHCARE PROFESSIONAL.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TCI ANESTHETIC USING STANDARD PK PUMPS. SUDDEN ONSET OF LEAKAGE OF PROPOFOL BACKWARDS THROUGH SYRINGE PLUNGER AND ONTO FLOOR. CRACK IN OUTER SYRINGE, POSSIBLE DEFECT ALSO IN PLUNGER. I HAVE NOT SEEN THIS PROBLEM WITH A TCI SYRINGE PREVIOUSLY. NO INJURY TO PATIENT OR HEALTHCARE PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451302 BD PLASTIPAK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1902237

    Patients

    Seq Age Sex Outcome Treatment
    1 Other