BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 25GA 5/8IN

    MDR report key: 10054226 · Received May 13, 2020

    Report

    Report Number
    3002682307-2020-00157
    Event Type
    Malfunction
    Date Received
    May 13, 2020
    Date of Event
    April 23, 2020
    Report Date
    May 20, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE PROVIDED LOT NUMBER 190715 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, THREE PICTURE SAMPLES WERE PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURE SAMPLES, THE CANNULA WAS OBSERVED CROSSING THROUGH THE SHIELD COMPONENT. ALTHOUGH AN EXACT CAUSE CANNOT BE DETERMINED, IT IS POSSIBLE THAT THE NEEDLE WAS BENT DURING THE SHIELD ASSEMBLY PROCESS DUE TO INCORRECT POSITIONING. THE MANUFACTURING PERSONNEL HAVE BEEN MADE AWARE OF THIS INCIDENT IN AN ATTEMPT TO INCREASE THE DETECTION OF THIS POTENTIAL DEFECT ON THE PRODUCTION FLOOR. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE NEEDLE 25GA 5/8IN EXPERIENCED THE NEEDLE PENETRATING THROUGH THE SHIELD WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING PRODUCTION ONE OF OUR OPERATORS WAS REMOVING THE NEEDLE FROM ITS OUTER POLYBAG AND THE NEEDLE STABBED THE OPERATOR AS IT WAS PIERCING OUT OF ITS HUB. THIS IS THE FIRST OCCURRENCE OF AN ISSUE LIKE THIS WITH YOUR NEEDLES BUT DUE THE DANGER BEHIND A DEFECT LIKE THIS.

    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 THE NEEDLE 25GA 5/8IN EXPERIENCED THE NEEDLE PENETRATING THROUGH THE SHIELD WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING PRODUCTION ONE OF OUR OPERATORS WAS REMOVING THE NEEDLE FROM ITS OUTER POLYBAG AND THE NEEDLE STABBED THE OPERATOR AS IT WAS PIERCING OUT OF ITS HUB. THIS IS THE FIRST OCCURRENCE OF AN ISSUE LIKE THIS WITH YOUR NEEDLES BUT DUE THE DANGER BEHIND A DEFECT LIKE THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    517845 NEEDLE 25GA 5/8IN NEEDLE FMI BECTON DICKINSON, S.A. 190715

    Patients

    Seq Age Sex Outcome Treatment
    1 Other