BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEN NDL 32G 4MM PRO 100 BOX AP

    MDR report key: 12485714 · Received September 16, 2021

    Report

    Report Number
    9616656-2021-01166
    Event Type
    Malfunction
    Date Received
    September 16, 2021
    Date of Event
    August 20, 2021
    Report Date
    October 12, 2021
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY TWO PHOTOS OF TWO 32G X 4MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 0091915, CAT. NO. 320566. VISUAL EXAMINATION OF THE RETURNED PHOTOS WAS CARRIED OUT AND NO ISSUES WERE OBSERVED. NO CLOG TEST COULD BE CARRIED OUT AS NO PHYSICAL SAMPLES WERE RETURNED. 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. BASED ON THE PHOTOS AND THE FACT NO PHYSICAL SAMPLES WERE RETURNED NO FURTHER INVESTIGATION CAN BE CARRIED OUT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PEN NDL 32G 4MM PRO 100 BOX AP WAS UNABLE TO DELIVER MEDICATION. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS RESISTANCE WHEN THE NEEDLE OF THE NEW PEN NEEDLE IS SUBCUTANEOUSLY INJECTED AND THE MEDICINE IS PUSHED, AND THE MEDICINE IS SPLASHED WHEN IT IS PULLED UP.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT PEN NDL 32G 4MM PRO 100 BOX AP WAS UNABLE TO DELIVER MEDICATION. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS RESISTANCE WHEN THE NEEDLE OF THE NEW PEN NEEDLE IS SUBCUTANEOUSLY INJECTED AND THE MEDICINE IS PUSHED, AND THE MEDICINE IS SPLASHED WHEN IT IS PULLED UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1382734 PEN NDL 32G 4MM PRO 100 BOX AP PEN NEEDLE FMI BECTON DICKINSON AND CO. 0091915

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown