BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 13370345 · Received January 27, 2022

    Report

    Report Number
    3003152976-2022-00029
    Event Type
    Malfunction
    Date Received
    January 27, 2022
    Date of Event
    January 10, 2022
    Report Date
    March 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

    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.

    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: 14-FEB-2022. H.6. INVESTIGATION: SEVERAL SAMPLES AND ONE PHOTO WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION OF THE PHOTO, SILICONE CAN BE OBSERVED, HOWEVER, IT CANNOT BE CONFIRMED IT IS IN EXCESS. ALL PHYSICAL SAMPLES WERE EVALUATED AND SILICONE WAS OBSERVED INSIDE THE SYRINGE BARREL. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2110055, 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 RESULTS VERIFIED THE AMOUNT OF SILICONE WAS WITHIN REQUIRED LIMITS. WHILE WE CANNOT IDENTIFY A DIRECT ISSUE, THE SILICONE WAS LIKELY VISIBLE DUE TO ISSUES RELATED TO POOR DISTRIBUTION INSIDE THE BARREL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS STUCK TO THE INSIDE WALLS OF THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THERE IS ALSO A NEW PROBLEM WITH THE 50ML SYRINGES, SILICONE AT THE PISTON STICKS TO THE WALLS OF THE SYRINGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS STUCK TO THE INSIDE WALLS OF THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: THERE IS ALSO A NEW PROBLEM WITH THE 50ML SYRINGES, SILICONE AT THE PISTON STICKS TO THE WALLS OF THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258202 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2110055

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown