BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿ PRO PEN NEEDLE

    MDR report key: 14138611 · Received April 18, 2022

    Report

    Report Number
    9616656-2022-00427
    Event Type
    Malfunction
    Date Received
    April 18, 2022
    Date of Event
    March 28, 2022
    Report Date
    April 20, 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

    H6: INVESTIGATION SUMMARY TWENTY FIVE SEALED 32G X 4MM PEN NEEDLE SAMPLES AND TWO PHOTOS WERE RETURNED FROM LOT NO. 1012832, CAT. NO. 320559. A FUNCTIONALITY TEST WAS CARRIED OUT ON ALL TWENTY FIVE SAMPLES AS PER Q-SOP-183-DL AND NO ISSUES WERE OBSERVED. MAGNIFIED EXAMINATION WAS ALSO CARRIED OUT ON ALL TWENTY FIVE 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD MICRO-FINE¿ PRO PEN NEEDLES WERE DIFFICULT TO OPERATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE WAS INSERTED ON THE ABDOMEN BUT THE PATIENT COULD NOT PUSH THE BUTTON OF INSULIN INJECTION. ANOTHER ISSUE WAS THAT THE PATIENT COULD NOT PUSH THE BUTTON OF INSULIN INJECTION. THE TWO ISSUES WERE REGISTERED AS UNABLE TO ACTIVATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD MICRO-FINE¿ PRO PEN NEEDLES WERE DIFFICULT TO OPERATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE WAS INSERTED ON THE ABDOMEN BUT THE PATIENT COULD NOT PUSH THE BUTTON OF INSULIN INJECTION. ANOTHER ISSUE WAS THAT THE PATIENT COULD NOT PUSH THE BUTTON OF INSULIN INJECTION. THE TWO ISSUES WERE REGISTERED AS UNABLE TO ACTIVATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2640240 BD MICRO-FINE¿ PRO PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 1012832

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown