BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿ PLUS PRO PEN NEEDLE

    MDR report key: 13559511 · Received February 18, 2022

    Report

    Report Number
    9616656-2022-00205
    Event Type
    Malfunction
    Date Received
    February 18, 2022
    Date of Event
    February 10, 2022
    Report Date
    March 17, 2022
    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

    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: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 02-MAR-2022. H.6. INVESTIGATION: THREE OPEN 32G X 4MM PEN NEEDLE SAMPLES AND THREE PHOTOS WERE RETURNED FROM LOT. NO. 1033651, CAT. NO. 320559. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED SAMPLES AND PHOTOS AND A BROKEN NON PATIENT END OF CANNULA WAS OBSERVED ON ALL THREE SAMPLES. A FUNCTIONALITY TEST WAS ALSO CARRIED OUT ON THE THREE SAMPLES 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. AS ALL SAMPLES RETURNED WERE OPEN IT IS NOT POSSIBLE TO CONFIRM THIS DEFECT TO BE MANUFACTURING RELATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD MICRO-FINE¿ PLUS PRO PEN NEEDLES WERE NOT FUNCTIONING CORRECTLY AND HAD DETACHMENT ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE PATIENT REPORTED ONE PEN NEEDLE WAS NOT ATTACHING TO THE PEN PROPERLY AND UPON DECAPPING TWO PEN NEEDLES WERE NOT DETACHED APPROPRIATELY RESULTING WITH THE OUTER COVER ONLY DETACHED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 3 BD MICRO-FINE¿ PLUS PRO PEN NEEDLES WERE NOT FUNCTIONING CORRECTLY AND HAD DETACHMENT ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER : THE PATIENT REPORTED ONE PEN NEEDLE WAS NOT ATTACHING TO THE PEN PROPERLY AND UPON DECAPPING TWO PEN NEEDLES WERE NOT DETACHED APPROPRIATELY RESULTING WITH THE OUTER COVER ONLY DETACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474192 BD MICRO-FINE¿ PLUS PRO PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 1033651

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown