BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 13453020 · Received February 4, 2022

    Report

    Report Number
    3003152976-2022-00046
    Event Type
    Malfunction
    Date Received
    February 4, 2022
    Date of Event
    January 21, 2022
    Report Date
    March 9, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 AS A DEFAULT A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: TWELVE 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, NO EXCESS OF SILICONE OR OTHER FOREIGN PARTICLES CAN BE OBSERVED IN ANY OF THE SAMPLES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2110137, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE CONTAINED FOREIGN MATTER IN THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ON A BATCH OF THE BD PLASTIPAK 50 ML BATCH 2110137, IT IS NOTICEABLE THAT THERE IS AN EXCESS OF SILICONE OIL ON THE PLUNGER."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE CONTAINED FOREIGN MATTER IN THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ON A BATCH OF THE BD PLASTIPAK 50 ML BATCH 2110137, IT IS NOTICEABLE THAT THERE IS AN EXCESS OF SILICONE OIL ON THE PLUNGER."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE CONTAINED FOREIGN MATTER IN THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ON A BATCH OF THE BD PLASTIPAK 50 ML BATCH 2110137, IT IS NOTICEABLE THAT THERE IS AN EXCESS OF SILICONE OIL ON THE PLUNGER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1421426 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2110137

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown