BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿+ PEN NEEDLE

    MDR report key: 14246805 · Received April 28, 2022

    Report

    Report Number
    9616656-2022-00476
    Event Type
    Malfunction
    Date Received
    April 28, 2022
    Date of Event
    April 12, 2022
    Report Date
    May 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES, D9: RETURNED TO MANUFACTURER ON: 10-MAY-2022. H6: INVESTIGATION SUMMARY: ONE OPEN 32G X 4MM PEN NEEDLE SAMPLE AND TWO PHOTOS WERE RETURNED FROM LOT. NO. 1160301, CAT. NO. 320136. A FUNCTIONALITY TEST AS PER Q-SOP-183-DL WAS CARRIED OUT ON THE RETURNED SAMPLE AND DAMAGE TO THE HUB WAS 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. THIS ISSUE MOST LIKELY OCCURRED DUE TO MISALIGNMENT AT THE PICK AND PLACE STATION IN ASSEMBLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PEN NEEDLE WOULD NOT ATTACH TO THE PEN ON THE BD MICRO-FINE¿+ PEN NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE PEN NEEDLE COULD NOT BE ATTACHED TO THE PEN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PEN NEEDLE WOULD NOT ATTACH TO THE PEN ON THE BD MICRO-FINE¿+ PEN NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE PEN NEEDLE COULD NOT BE ATTACHED TO THE PEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105560 BD MICRO-FINE¿+ PEN NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND CO. 1160301

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown