BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 30GA 1/2IN

    MDR report key: 10071366 · Received May 19, 2020

    Report

    Report Number
    3002682307-2020-00163
    Event Type
    Malfunction
    Date Received
    May 19, 2020
    Date of Event
    May 4, 2020
    Report Date
    May 27, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903040001
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 180319 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. AS SAMPLES WERE UNAVAILABLE FOR THIS INCIDENT, OUR QUALITY TEAM OBTAINED TWENTY RETAINED SAMPLES OF THE SAME LOT NUMBER FROM THE MANUFACTURING FACILITY FOR FURTHER EVALUATION. THE RETAINED SAMPLES WERE ASSEMBLED WITH A CAVERJET SYRINGE PER THE INSTRUCTIONS. THE NEEDLE HUB WAS POSITIONED WITH A SLIGHTLY ROTATIONAL MOVEMENT. NONE OF THE PRODUCTS SHOWED ANY SIGNS OF DEFECT OR LEAKAGE. BASED ON THE INVESTIGATION RESULTS, A DEFINITE CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LEAKAGE OCCURRED DURING USE WITH A NEEDLE 30GA 1/2IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "PATIENT REPORTED THAT THE LIQUID LEAKED IN SYRINGE¿S TOP WHERE THE NEEDLE IS INSERTED."

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT LEAKAGE OCCURRED DURING USE WITH A NEEDLE 30GA 1/2IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "PATIENT REPORTED THAT THE LIQUID LEAKED IN SYRINGE¿S TOP WHERE THE NEEDLE IS INSERTED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536911 NEEDLE 30GA 1/2IN NEEDLE FMI BECTON DICKINSON, S.A. 180319 00382903040001

    Patients

    Seq Age Sex Outcome Treatment
    1 Other