BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ LUER-LOK¿ SYRINGE

    MDR report key: 17438446 · Received August 1, 2023

    Report

    Report Number
    3003152976-2023-00307
    Event Type
    Malfunction
    Date Received
    August 1, 2023
    Date of Event
    July 13, 2023
    Report Date
    August 11, 2023
    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

    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

    H6: INVESTIGATION SUMMARY: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION HAVE BEEN PROVIDED FOR EVALUATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2203144, 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 THE REPORTED LOT AND FOUND TO BE WITHIN SPECIFICATION. BASED ON THE QUALITY TEAM'S INVESTIGATION, A ROOT CAUSE CANNOT BE IDENTIFIED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD PLASTIPAK¿ LUER-LOK¿ SYRINGES HAD FOREIGN LUBRICANTS IN THEIR PISTONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "ABNORMAL PRESENCE OF LARGE QUANTITIES OF LUBRICANTS IN SYRINGE PISTONS".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD PLASTIPAK¿ LUER-LOK¿ SYRINGES HAD FOREIGN LUBRICANTS IN THEIR PISTONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "ABNORMAL PRESENCE OF LARGE QUANTITIES OF LUBRICANTS IN SYRINGE PISTONS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1843816 BD PLASTIPAK¿ LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2203144

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown