BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE 30GA 1/2IN

    MDR report key: 9931555 · Received April 6, 2020

    Report

    Report Number
    3002682307-2020-00125
    Event Type
    Malfunction
    Date Received
    April 6, 2020
    Date of Event
    April 2, 2020
    Report Date
    April 2, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED LOT NUMBER 180930. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. TAKING INTO ACCOUNT THE AVAILABLE FEEDBACK OF "THE APPLICATION NEEDLE JUMPS OUT WHEN HE IS GOING TO APPLY THE MEDICATION¿ " WE UNDERSTAND THAT A DEFECTIVE HUB CONNECTION ISSUE TOOK PLACE. BASED ON PAST EXPERIENCES, IT IS POSSIBLE THAT THE CONNECTIVITY ISSUE WAS THE RESULT OF DEFECTIVE LUER DIMENSIONS OR DAMAGES IN THE SYRINGE TIP. THIS INCIDENT COULD ALSO BE RELATED TO AN INSUFFICIENT ADJUSTMENT BETWEEN THE DEVICES BY THE END USER. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE MANUFACTURING PROCESS FOR THIS DEFECT AND OTHER EMERGING TRENDS. ROOT CAUSE DESCRIPTION: POSSIBLE INCORRECT HANDLING OF THE PRODUCT. RATIONALE: SINCE COMPLAINT IS NOT POSSIBLE TO CONFIRM, DHR SHOW NO ABNORMALITIES OR ISSUES AND NO COMPLAINTS FROM OTHER CUSTOMERS, IT WAS DETERMINED THAT NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE THE NEEDLE SEPARATES FROM SYRINGE WITH A BD NEEDLE 30GA 1/2IN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE APPLICATION NEEDLE JUMPS OUT WHEN HE IS GOING TO APPLY THE MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393094 BD NEEDLE 30GA 1/2IN HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 180930

    Patients

    Seq Age Sex Outcome Treatment
    1 Other