BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ LUER-LOK¿ SYRINGE

    MDR report key: 14740011 · Received June 18, 2022

    Report

    Report Number
    3003152976-2022-00279
    Event Type
    Malfunction
    Date Received
    June 18, 2022
    Date of Event
    May 23, 2022
    Report Date
    July 7, 2022
    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

    DATE OF EVENT: UNKNOWN. 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: 06-JUN-2022. H6: INVESTIGATION SUMMARY: ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, THE WHITE DOT AS DESCRIBED WAS OBSERVED. FURTHER EVALUATION IDENTIFIED THIS IS AN EMPTY SPACE EMBEDDED WITHIN THE SYRINGE BARREL DUE TO A LACK OF COMPACTION DURING THE MOLDING PROCESS. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2201051, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED ISSUE. MOLDING PARAMETERS WERE REVIEWED AND VERIFIED EQUIPMENT WAS OPERATING UNDER SPECIFIED LIMITS. 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. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, IT WAS DETERMINED THIS INCIDENT OCCURRED DURING THE MOLDING PROCESS DUE TO AN INCOMPLETE FILLING OF POLYPROPYLENE IN THE MOLD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND WITHIN THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: PRESENCE OF A WHITE MARK BETWEEN THE FIRST AND SECOND GRADUATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND WITHIN THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: PRESENCE OF A WHITE MARK BETWEEN THE FIRST AND SECOND GRADUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1398033 BD PLASTIPAK¿ LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2201051

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown