BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ LUER-LOK¿ SYRINGE

    MDR report key: 15710675 · Received November 1, 2022

    Report

    Report Number
    3003152976-2022-00492
    Event Type
    Malfunction
    Date Received
    November 1, 2022
    Date of Event
    October 10, 2022
    Report Date
    December 13, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903008698
    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

    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: 03-OCT-2022. H6: INVESTIGATION SUMMARY: ONE SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, THE TIP WAS OBSERVED TO BE DAMAGED. IT WAS ALSO NOTED THAT THE PACKAGING WAS DAMAGED AT THE SAME POINT AS THE TIP, INDICATING THE DAMAGE TOOK PLACE AFTER THE PRODUCT WAS PACKAGED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2111099, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. 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. MANUFACTURING RECORDS ESTABLISH ALL QUALITY PROCESSES WERE CARRIED OUT TO PROCEDURE. WHILE WE CANNOT IDENTIFY A DIRECT ISSUE, IT IS LIKELY THE DAMAGE OCCURRED DURING THE PACKAGING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIPS OF 2 BD PLASTIPAK¿ LUER-LOK¿ SYRINGES WERE DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "THE LUER LOCK TIP IS "MELTED" AND DEFORMED, NOT ALLOWING TO FILL THE SYRINGE"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TIPS OF 2 BD PLASTIPAK¿ LUER-LOK¿ SYRINGES WERE DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "THE LUER LOCK TIP IS "MELTED" AND DEFORMED, NOT ALLOWING TO FILL THE SYRINGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1058540 BD PLASTIPAK¿ LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2111099 00382903008698

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown