BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK LEUR LOK SYRINGE

    MDR report key: 8667024 · Received June 4, 2019

    Report

    Report Number
    3003152976-2019-00377
    Event Type
    Malfunction
    Date Received
    June 4, 2019
    Date of Event
    May 20, 2019
    Report Date
    June 18, 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
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1811351, MEDICAL DEVICE EXPIRATION DATE: 10/31/2023, DEVICE MANUFACTURE DATE: 11/5/2018, MEDICAL DEVICE LOT #: 1812352, MEDICAL DEVICE EXPIRATION DATE: 11/30/2023, DEVICE MANUFACTURE DATE: 12/5/2018. INVESTIGATION SUMMARY: ONE PHOTO AND ONE SAMPLE WAS PROVIDED 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. THE STOPPER WAS DISASSEMBLED, NO DAMAGE OR MOLDING DEFECTIVE OBSERVED THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT. A DEVICE HISTORY WAS PERFORMED FOR SUSPECTED LOTS 1811351 AND 1812352 FOUND NO CONFORMANCES RELATED TO THE REPORTED ISSUE DURING PRODUCTION OF EITHER BATCH. THIS ISSUE WAS DETERMINED TO HAVE OCCURRED AS A RESULT OF IMPROPER ALIGNMENT OF THE PLUNGER/STOPPER TO THE BARREL DURING ASSEMBLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PLASTIPAK¿ LEUR LOK SYRINGE STOPPER WAS DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT SYRINGES 60 ML HAS DEFORMED STOPPER. IT CONCERNS 300223 - LOT NUMBER 1811351 OR 1812352. THE SYRINGE WAS NOT USED ON PATIENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PLASTIPAK¿ LEUR LOK SYRINGE STOPPER WAS DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THAT SYRINGES 60 ML HAS DEFORMED STOPPER. IT CONCERNS 300223 - LOT NUMBER 1811351 OR 1812352. THE SYRINGE WAS NOT USED ON PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458663 BD PLASTIPAK LEUR LOK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other