BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGE

    MDR report key: 16542579 · Received March 14, 2023

    Report

    Report Number
    3003152976-2023-00066
    Event Type
    Malfunction
    Date Received
    March 14, 2023
    Date of Event
    February 21, 2023
    Report Date
    April 19, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 16-MAR-2023. H6: INVESTIGATION SUMMARY SAMPLES AND PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL EVALUATION, PLASTIC FIBERS ON THE TIP OF SOME OF THE SYRINGES PROVIDED WERE OBSERVED, THEREFORE THE INCIDENT IS CONFIRMED. A REVIEW OF THE DEVICE HISTORY WAS PERFORMED FOR LOT 2202072, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THE REPORTED PROBLEM WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. 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. POSSIBLE ROOT CAUSE IS ASSOCIATED WITH THE MOLDING PROCESS. H3 OTHER TEXT : SEE H10.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 8 BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGES HAD SHARP PLASTIC MOLDING DEFECTS ON THEIR TIPS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER HAS FOUND 8 SYRINGES OUT OF 200 SAMPLED WITH A DEFECT ¿ PLASTIC FIBERS ON THE TIPS."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 8 BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGES HAD SHARP PLASTIC MOLDING DEFECTS ON THEIR TIPS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER HAS FOUND 8 SYRINGES OUT OF 200 SAMPLED WITH A DEFECT ¿ PLASTIC FIBRES ON THE TIPS".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1051115 BD PLASTIPAK¿ HYPODERMIC LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2202072

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown