BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL SYRINGE 50ML

    MDR report key: 13760335 · Received March 14, 2022

    Report

    Report Number
    3003152976-2022-00103
    Event Type
    Malfunction
    Date Received
    March 14, 2022
    Date of Event
    February 26, 2022
    Report Date
    April 22, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2111038, MEDICAL DEVICE EXPIRATION DATE: 2026-10-31, DEVICE MANUFACTURE DATE: 2021-11-30; MEDICAL DEVICE LOT #: 2112022, MEDICAL DEVICE EXPIRATION DATE: 2026-11-30, DEVICE MANUFACTURE DATE: 2021-12-09; MEDICAL DEVICE LOT #: 2112024, MEDICAL DEVICE EXPIRATION DATE: 2026-11-30, DEVICE MANUFACTURE DATE: 2021-12-09. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES. D9: RETURNED TO MANUFACTURER ON: 15-MAR-2022. H6: INVESTIGATION SUMMARY THREE SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, NO FOREIGN MATTER OR LUBRICANT WAS OBSERVED WITHIN ANY OF THE SYRINGES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOTS 2111038, 211202 AND 2112024, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. LUBRICANT IS EMPLOYED DURING THE SYRINGE ASSEMBLY PROCESS TO LUBRICATE THE CYLINDERS IN THE SILICONE STATION. THE SILICONE EMPLOYED IN THIS PRODUCT IS A MEDICAL GRADE SILICONE AUTHORIZED FOR PRODUCT USE. SILICONE CONTENT TESTS ARE PERFORMED DURING THE MANUFACTURING PROCESS OF EACH LOT NUMBER. TESTING WAS PERFORMED ON THE RETURNED SAMPLES, ALL PRODUCT MET REQUIRED SPECIFICATION, AND NO EXCESS SILICONE WAS IDENTIFIED IN ANY OF THE SAMPLES. SILICONE CAN BE VISIBLE DUE TO ISSUES RELATED TO POOR DISTRIBUTION INSIDE THE BARREL. AS NO DEFECT WAS OBSERVED IN THE RETURNED SAMPLES AND DEVICE RECORDS DO NOT INDICATE ANY ISSUES OCCURRED DURING MANUFACTURING, A DEFINITIVE ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS CANNOT BE IDENTIFIED AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD CONVENTIONAL SYRINGE 50ML HAD A GREASY FOREIGN MATTER IN THE FLUID PATHWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CLIENT: "WHEN OPENING A NEW 50ML SYRINGE, I NOTICED THAT THE PLUNGER CONTAINED A BIT OF A GREASY SUBSTANCE, SOME OF IT STUCK TO THE INSIDE OF THE SYRINGE ITSELF."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD CONVENTIONAL SYRINGE 50ML HAD A GREASY FOREIGN MATTER IN THE FLUID PATHWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CLIENT: "WHEN OPENING A NEW 50ML SYRINGE, I NOTICED THAT THE PLUNGER CONTAINED A BIT OF A GREASY SUBSTANCE, SOME OF IT STUCK TO THE INSIDE OF THE SYRINGE ITSELF."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281624 BD CONVENTIONAL SYRINGE 50ML PISTON SYRINGE FMF BECTON DICKINSON, S.A. SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown