BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ - 3-PIECE SYRINGE

    MDR report key: 14778037 · Received June 22, 2022

    Report

    Report Number
    3003152976-2022-00288
    Event Type
    Malfunction
    Date Received
    June 22, 2022
    Date of Event
    May 20, 2022
    Report Date
    July 28, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    K182589
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    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: D9: DEVICE AVAILABLE FOR EVAL YES, D9: RETURNED TO MANUFACTURER ON: 5-JUL-2022 . H6: INVESTIGATION SUMMARY: MULTIPLE SAMPLES AND PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, THE SCALE MARKING WAS OBSERVED TO BE CLEAR OR NOT PRINTED, VERIFYING THE REPORTED INCIDENT. 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 THE REPORTED FAILURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USING A BD PLASTIPAK¿ - 3-PIECE SYRINGE, THE SCALE MARKING WERE MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SYRINGE HAS NO MEASUREMENT MARKINGS & UNABLE TO USE. FAULTY SYRINGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USING A BD PLASTIPAK¿ - 3-PIECE SYRINGE, THE SCALE MARKING WERE MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE SYRINGE HAS NO MEASUREMENT MARKINGS & UNABLE TO USE. FAULTY SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265280 BD PLASTIPAK¿ - 3-PIECE SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2203076

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown