BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE ULTRA¿ PEN NEEDLE

    MDR report key: 14681668 · Received June 13, 2022

    Report

    Report Number
    9616656-2022-00615
    Event Type
    Malfunction
    Date Received
    June 13, 2022
    Date of Event
    May 27, 2022
    Report Date
    August 5, 2022
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUTION?: YES. D9: RETURNED TO MANUFACTURER ON: 30-JUN-2022. H6: INVESTIGATION SUMMARY NINE SEALED 32 G X 4MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT NO. 1062594, CAT. NO. 320141. A CLOG TEST WAS CARRIED OUT AS PER Q-SOP-183-DL AND NO ISSUES WERE OBSERVED. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. NO ISSUES WERE OBSERVED WITH THE RETURNED SAMPLES THEREFORE NO ROOT CAUSE CAN BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICRO-FINE ULTRA¿ PEN NEEDLE FAILED TO DELIVER MEDICATION DURING THE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHARMACY INFORMS US THAT A CUSTOMER COMPLAINED THAT SOME NEEDLES ARE NOT PERMEABLE. HE NEEDS 3-5 NEEDLES UNTIL AN INJECTION WOULD WORK."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICRO-FINE ULTRA¿ PEN NEEDLE FAILED TO DELIVER MEDICATION DURING THE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PHARMACY INFORMS US THAT A CUSTOMER COMPLAINED THAT SOME NEEDLES ARE NOT PERMEABLE. HE NEEDS 3-5 NEEDLES UNTIL AN INJECTION WOULD WORK."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1248863 BD MICRO-FINE ULTRA¿ PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 1062594

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown