BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 15080729 · Received July 21, 2022

    Report

    Report Number
    3003152976-2022-00329
    Event Type
    Malfunction
    Date Received
    July 21, 2022
    Date of Event
    June 17, 2022
    Report Date
    August 29, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL: YES. D10: RETURNED TO MANUFACTURER ON: 19-JUL-2022. H6: INVESTIGATION SUMMARY: ONE CASE OF SAMPLES WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED AND FOUND THE SCALE WAS EITHER NOT PRINTED OR PARTIALLY PRINTED, VERIFYING THE REPORTED ISSUE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2203076, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE, HOWEVER, THERE WAS A NOTE IN THE INCIDENT LOG DOCUMENTING THAT THE PADS IN THE MARKING MACHINE NEEDED TO BE CHANGED. BASED ON OUR INVESTIGATION, IT IS LIKELY A MISALIGNMENT OCCURRED BETWEEN THE PADS AND BARREL WHEN TRANSFERRING THE SCALE, REQUIRING THE PADS TO BE CHANGED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE HAD ISSUES WITH LIGHT SCALE MARKINGS, WHILE ANOTHER HAD NO SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PHYSICAL SYRINGES EITHER HAVE NO MARKINGS ON AT ALL OR THEY ARE VERY FEINT. IT IS ONLY THE FIRST 1 ON THE STRIP THAT CAN BE READ."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ONE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE HAD ISSUES WITH LIGHT SCALE MARKINGS, WHILE ANOTHER HAD NO SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE PHYSICAL SYRINGES EITHER HAVE NO MARKINGS ON AT ALL OR THEY ARE VERY FEINT. IT IS ONLY THE FIRST 1 ON THE STRIP THAT CAN BE READ".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89584 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2203076

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown