BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD ¿ PRO SYRINGE

    MDR report key: 15209927 · Received August 11, 2022

    Report

    Report Number
    2243072-2022-01316
    Event Type
    Malfunction
    Date Received
    August 11, 2022
    Date of Event
    April 7, 2021
    Report Date
    August 25, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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

    H.6. INVESTIGATION SUMMARY: THERE ARE NO SAMPLES AND NO PHOTOGRAPH ALONG WITH THE REPORTED COMPLAINT OF ASPIRATION DIFFICULTY. THE DHR OF MATERIAL NO. 307930 WITH BATCH NO. 0101455 WAS CHECKED AND THERE WAS NO QUALITY NOTIFICATION FOUND ON THIS LOT NO. FROM ITS PRODUCTION DATE TO ITS DISPATCH ON DATE. THE INVESTIGATING TEAM HAS USED THE RETENTION SAMPLES OF MATERIAL NUMBER 307930 AND LOT NUMBER 0101455 FOR INVESTIGATING THE REPORTED DEFECT. THE INVESTIGATION AND SIMULATION WERE CARRIED OUT ON TEN RETENTION SAMPLES WHERE THE INVESTIGATING TEAM HAS VISUALLY TESTED THE SAMPLES FOR ASPIRATION DIFFICULTY AND NO ASPIRATION DIFFICULTY WAS FOUND IN THE TEN RETENTION SAMPLES. ASPIRATION DIFFICULTY IS A FUNCTIONAL TEST AND TO CONFIRM THIS DEFECT AN ORIGINAL SAMPLE WILL BE REQUIRED. SINCE THERE ARE NO SAMPLES OR PHOTOGRAPHS AVAILABLE THIS COMPLAINT CANNOT BE CONFIRMED OR INVESTIGATED FURTHER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD EMERALD ¿ PRO SYRINGES DID NOT MEET THE MINIMUM SPECIFICATION FOR PLUNGER PUSHOUT FORCE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING TESTING CONDUCTED IN THE R&D LAB AS PART OF REAL TIME AGING STUDY HY-SH-13840 TWO (2) 10ML EMERALD PRO SYRINGES FROM A POSSIBLE PRODUCTION LOT (CATALOG 307930 LOT 0101455) DID NOT MEET THE MINIMUM SPECIFICATION FOR PLUNGER PUSHOUT FORCE AT T=0. THE FAILED SAMPLES HAVE BEEN RETAINED BUT WILL LIKELY BE HELD FOR FURTHER INVESTIGATION BY R&D/QUALITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD EMERALD ¿ PRO SYRINGES DID NOT MEET THE MINIMUM SPECIFICATION FOR PLUNGER PUSHOUT FORCE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING TESTING CONDUCTED IN THE R&D LAB AS PART OF REAL TIME AGING STUDY HY-SH-13840 TWO (2) 10ML EMERALD PRO SYRINGES FROM A POSSIBLE PRODUCTION LOT (CATALOG 307930 LOT 0101455) DID NOT MEET THE MINIMUM SPECIFICATION FOR PLUNGER PUSHOUT FORCE AT T=0. THE FAILED SAMPLES HAVE BEEN RETAINED BUT WILL LIKELY BE HELD FOR FURTHER INVESTIGATION BY R&D/QUALITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1721292 BD EMERALD ¿ PRO SYRINGE PISTON SYRINGE FMF BECTON DICKINSON 0101455

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown