BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL

    MDR report key: 8541894 · Received April 23, 2019

    Report

    Report Number
    3003152976-2019-00285
    Event Type
    Malfunction
    Date Received
    April 23, 2019
    Date of Event
    March 29, 2019
    Report Date
    May 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: ONE SAMPLE AND ONE PHOTO WERE RETURNED TO OUR QUALITY ENGINEER FOR INVESTIGATION. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THE STOPPER WAS INCORRECTLY ASSEMBLED TO THE PLUNGER, DISTORTED AGAINST THE BARREL WALL. A DEVICE HISTORY WAS PERFORMED AND FOUND NO NO-CONFORMANCES RELATED TO THE REPORTED ISSUE DURING PRODUCT OF BATCH 1811230. A CAMERA SYSTEM IS THE ASSEMBLY STATION IS USED TO DETECT THIS ISSUE. ALTHOUGH THERE WAS NO INSTANCE WAS IDENTIFIED, IT WAS DETERMINED THIS MALFUNCTION OCCURRED AS A RESULT OF IMPROPER ALIGNMENT OF THE PLUNGER/STOPPER TO THE BARREL DURING ASSEMBLY. A PROJECT WAS INITIATED TO FURTHER EVALUATE THIS ISSUE AND REDUCE ANY REOCCURRENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SYRINGE 50ML LL EXPERIENCED STOPPER DEFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHYSICAL DEFECT DISCOVERED WITH SYRINGE PLUNGER WHILE SPRAYING INTO AN ASEPTIC AREA. SYRINGE PLUNGER IS DEFORMED.

    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 THE SYRINGE 50ML LL EXPERIENCED STOPPER DEFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PHYSICAL DEFECT DISCOVERED WITH SYRINGE PLUNGER WHILE SPRAYING INTO AN ASEPTIC AREA. SYRINGE PLUNGER IS DEFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335881 SYRINGE 50ML LL SYRINGE FMF BECTON DICKINSON, S.A. 1811230

    Patients

    Seq Age Sex Outcome Treatment
    1 Other