BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 14653125 · Received June 10, 2022

    Report

    Report Number
    3003152976-2022-00257
    Event Type
    Malfunction
    Date Received
    June 10, 2022
    Date of Event
    May 13, 2022
    Report Date
    June 15, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    H.6 INVESTIGATION SUMMARY: MULTIPLE PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, SILICONE IS VISIBLE INSIDE THE SYRINGE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2202013, 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. RESULTS WERE REVIEWED FOR LOT 2202013 AND FOUND TO BE WITHIN SPECIFICATION. WHILE WE CANNOT IDENTIFY A DIRECT ISSUE, SILICONE CAN BE VISIBLE DUE TO ISSUES RELATED TO POOR DISTRIBUTION INSIDE THE BARREL. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND WITHIN THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISCOVERED AN OILY LIQUID IN THE SYRINGE WHEN OPENED THE OUTER PACKAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND WITHIN THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DISCOVERED AN OILY LIQUID IN THE SYRINGE WHEN OPENED THE OUTER PACKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631432 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2202013

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown