BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGE

    MDR report key: 15825359 · Received November 18, 2022

    Report

    Report Number
    3003152976-2022-00525
    Event Type
    Malfunction
    Date Received
    November 18, 2022
    Date of Event
    October 26, 2022
    Report Date
    December 14, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903059591
    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

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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: 14-NOV-2022. H6: INVESTIGATION SUMMARY: ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT WAS OBSERVED THE SCALE WAS NOT PRINTED ON THE SYRINGE, VERIFYING THE REPORTED INCIDENT. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2201064, FINDING INCIDENTS RELATED TO JAMMING AND BARREL DAMAGE WITHIN THE MARKING MACHINE, WHICH CAN LEAD TO THE SCALE NOT PRINTING PROPERLY AS SEEN IN THE SAMPLE PROVIDED. ONCE DETECTED, THE ISSUE WAS CORRECTED BY THE MECHANICAL TEAM. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE AND LOT SIZE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. BASED ON OUR QUALITY TEAM'S INVESTIGATION IT WAS DETERMINED THIS INCIDENT IS RELATED TO THE ISSUES FOUND IN THE MARKING MACHINE DURING MANUFACTURING, CAUSING THE SCALE NOT PRINTING ON THE SYRINGE, THE IMPACTED PIECE NOT PROPERLY IDENTIFIED AND DISCARDED. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGE HAD A LACK OF SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "LACK OF GRADUATIONS ON THE SYRINGE. CLINICAL CONSEQUENCES: CHANGE OF SYRINGE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGE HAD A LACK OF SCALE MARKINGS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "LACK OF GRADUATIONS ON THE SYRINGE. CLINICAL CONSEQUENCES: CHANGE OF SYRINGE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237727 BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2201064 00382903059591

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown