BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 13534007 · Received February 15, 2022

    Report

    Report Number
    3003152976-2022-00065
    Event Type
    Malfunction
    Date Received
    February 15, 2022
    Date of Event
    February 2, 2022
    Report Date
    April 21, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 09-MAR-2022. H.6. INVESTIGATION: SEVERAL SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION OF THE PRODUCT, SILICONE IS VISIBLE, HOWEVER, IT CANNOT BE CONFIRMED IT IS IN EXCESS. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2111031, 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.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE HAD EXCESS SILICONE ON IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "WE OBSERVE AN EXCESS OF LUBRICANT IN THE 50ML SYRINGES OF LOT 2111031."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE HAD EXCESS SILICONE ON IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "WE OBSERVE AN EXCESS OF LUBRICANT IN THE 50ML SYRINGES OF LOT 2111031."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524291 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2111031

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown