BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICROFINE¿ + PEN NEEDLE

    MDR report key: 16538532 · Received March 14, 2023

    Report

    Report Number
    9616656-2023-00213
    Event Type
    Malfunction
    Date Received
    March 14, 2023
    Date of Event
    February 21, 2023
    Report Date
    April 7, 2023
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 13-MAR-2023. TWO OPEN 31G X 5MM PEN NEEDLE SAMPLES AND THREE PHOTOS WERE RETURNED FROM LOT. NO. 1243863, CAT. NO. 320129. A CLOG TEST AS PER Q-SOP-183-DL WAS CARRIED OUT ON RETURNED SAMPLES 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. H3 OTHER TEXT : SEE H10.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICROFINE¿ + PEN NEEDLE DID NOT DELIVER MEDICATION DURING THE PRIMING PROCESS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "STATING THAT THE DRUG SOLUTION DID NOT COME OUT UPON PRIMING".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MICROFINE¿ + PEN NEEDLE DID NOT DELIVER MEDICATION DURING THE PRIMING PROCESS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "STATING THAT THE DRUG SOLUTION DID NOT COME OUT UPON PRIMING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834817 BD MICROFINE¿ + PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 1243863

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown