BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EMERALD 10ML SYRINGE

    MDR report key: 12774026 · Received November 8, 2021

    Report

    Report Number
    3002682307-2021-00601
    Event Type
    Malfunction
    Date Received
    November 8, 2021
    Date of Event
    September 13, 2021
    Report Date
    December 3, 2021
    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

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2105265. MEDICAL DEVICE EXPIRATION DATE: 04/30/2026. DEVICE MANUFACTURE DATE: 05/20/2021. MEDICAL DEVICE LOT #: 2102266. MEDICAL DEVICE EXPIRATION DATE: 01/31/2026. DEVICE MANUFACTURE DATE: 02/25/2021. MEDICAL DEVICE LOT #: 2103229. MEDICAL DEVICE EXPIRATION DATE: 02/28/2026. DEVICE MANUFACTURE DATE: 03/16/2021. 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: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 2103229. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS SAMPLES WERE UNAVAILABLE FOR RETURN, OUR QUALITY TEAM OBTAINED TWENTY RETAINED SAMPLES FOR FURTHER EVALUATION. THE RETAINED SAMPLES WERE EXAMINED AND NO DEFECTS COULD BE IDENTIFIED. THE MATERIAL USED TO MANUFACTURE THE EMERALD SYRINGES HAS BEEN SELECTED AND TESTED TO RESIST NORMAL CONDITIONS OF USE. THE ASSEMBLY MACHINES HAVE AN INLINE DETECTION SYSTEM WHICH INSPECTS ALL PRODUCT AND AUTOMATICALLY REJECTS ANY DAMAGED PARTS IDENTIFIED, SUCH AS DAMAGED STOPPERS.

    Description of Event or Problem · 0

    IT WAS REPORTED 3 BD EMERALD 10ML SYRINGES HAD A DEFECTIVE STOPPERS AND DAMAGED PLUNGER RODS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "POOR QUALITY PLUNGER RUBBER OF THE 10 ML LUER SYRINGE, DEFECTS IN DILUTION AND INJECTION, INACCURATE DOSE WHEN PREPARING ANAESTHETIC..."

    Description of Event or Problem · 0

    IT WAS REPORTED 3 BD EMERALD 10ML SYRINGES HAD A DEFECTIVE STOPPERS AND DAMAGED PLUNGER RODS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "POOR QUALITY PLUNGER RUBBER OF THE 10 ML LUER SYRINGE, DEFECTS IN DILUTION AND INJECTION, INACCURATE DOSE WHEN PREPARING ANAESTHETIC".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1666924 BD EMERALD 10ML SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. SEE H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown