BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROLANCE HYPODERMIC NEEDLE 21G X 1.5" GREEN

    MDR report key: 16114009 · Received January 6, 2023

    Report

    Report Number
    3002682307-2022-00362
    Event Type
    Malfunction
    Date Received
    January 6, 2023
    Date of Event
    December 10, 2022
    Report Date
    February 7, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    UDI-DI
    00382903044320
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 304432 AND LOT NUMBER 220342. 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. TO AID IN THE INVESTIGATION OF THIS ISSUE, ONE (1) PICTURE SAMPLE WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM. THROUGH EXAMINATION OF THE PICTURE, A POORLY FORMED BEVEL WAS OBSERVED, CONFIRMING THE REPORTED INCIDENT. DURING THE ASSEMBLY PROCESS, CANNULA POINT CONDITION IS ROUTINELY TESTED. EVERY LOT PRODUCED IS SUBJECTED TO PENETRABILITY TESTS BEFORE RELEASE. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THIS WAS AN ISOLATED INCIDENT WITH AN UNLIKELY CHANCE OF RECURRENCE. THE CANNULA COMPONENTS ARE PROVIDED IN CARTRIDGES FROM A SUPPLIER LOCATION; THEREFORE, A SUPPLIER CORRECTIVE ACTION REQUEST HAS BEEN INITIATED WITH THE CANNULA SUPPLIER IN RESPONSE TO THIS INCIDENT. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD MICROLANCE HYPODERMIC NEEDLE 21G X 1.5" GREEN THE NEEDLE WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I WAS USING THE PRODUCT MICROLANCE 3 AND I NOTICED THAT THE END OF THE NEEDLE WAS DEFECTIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD MICROLANCE HYPODERMIC NEEDLE 21G X 1.5" GREEN THE NEEDLE WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: I WAS USING THE PRODUCT MICROLANCE 3 AND I NOTICED THAT THE END OF THE NEEDLE WAS DEFECTIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459687 BD MICROLANCE HYPODERMIC NEEDLE 21G X 1.5" GREEN HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON, S.A. 220342 00382903044320

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown