BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGES

    MDR report key: 17130791 · Received June 14, 2023

    Report

    Report Number
    3003152976-2023-00230
    Event Type
    Malfunction
    Date Received
    June 14, 2023
    Date of Event
    May 23, 2023
    Report Date
    August 4, 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

    H.6. INVESTIGATION SUMMARY: PHOTOS RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL EVALUATION, POLYPROPYLENE BURR/FLASH ATTACHED TO THE TIP OF THE SYRINGE IS OBSERVED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2201051, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES FROM THE SAME AND TWO ADDITIONAL LOTS WERE EVALUATED, MOLDING DEFECT/FLASH WAS IDENTIFIED. 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. A PROJECT HAS BEEN INITIATED TO REDUCE THIS FAILURE WITHIN OUR PRODUCTS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    H.3. 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 PRIOR TO USE WITH 315 BD PLASTIPAK¿ SYRINGES "PLASTIC FIBERS" WERE DISCOVERED AT THE TIP OF SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SMALL PLASTIC FIBERS AROUND THE TIP OF THE SYRINGES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH 315 BD PLASTIPAK¿ SYRINGES "PLASTIC FIBERS" WERE DISCOVERED AT THE TIP OF SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SMALL PLASTIC FIBERS AROUND THE TIP OF THE SYRINGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1956822 BD PLASTIPAK¿ SYRINGES PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2203051

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown