BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK HYPODERMIC LUER-LOK SYRINGE

    MDR report key: 11403015 · Received March 3, 2021

    Report

    Report Number
    3003152976-2021-00115
    Event Type
    Malfunction
    Date Received
    March 3, 2021
    Date of Event
    February 4, 2021
    Report Date
    April 6, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: ONE PHOTO SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, THE SCALE IS OBSERVED TO BE MISSING FROM THE SYRINGE, VERIFYING THE REPORTED FAILURE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2004017, FINDING ONE ANNOTATION RELATED TO THIS DEFECT. DURING THE MARKING PROCESS, AN INCIDENT WAS DETECTED RELATED TO A FAILURE IN THE PATTERS THAT TRANSFER THE INK TO THE BARREL. ONCE DETECTED, THE MECHANICAL TEAM REPAIRED THE FAILURE AND DEFECTIVE PRODUCT WAS SCRAPPED. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. BASED ON OUR INVESTIGATION, IT WAS DETERMINED THIS DEFECT IS RELATED TO THE FAILURE DETECTED DURING THE MARKING PROCESS, THE REPORTED UNIT NOT BEING PROPERLY DETECTED AND DISCARDED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGE WAS MISSING THE SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BD PLASTIPAK SYRINGE WITHOUT MARKING . THERE WAS ONLY ONE IN THE BOX."

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGE WAS MISSING THE SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "BD PLASTIPAK SYRINGE WITHOUT MARKING. THERE WAS ONLY ONE IN THE BOX".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300354 BD PLASTIPAK HYPODERMIC LUER-LOK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2004017

    Patients

    Seq Age Sex Outcome Treatment
    1