BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿ INSULIN PEN NEEDLE

    MDR report key: 7534499 · Received May 22, 2018

    Report

    Report Number
    9616656-2018-00115
    Event Type
    Malfunction
    Date Received
    May 22, 2018
    Date of Event
    May 17, 2018
    Report Date
    May 23, 2018
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K051899
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE PHOTO OF A 29G X 12.7MM PEN NEEDLE SAMPLES WAS RETURNED FROM LOT. NO. 6173511, CAT. NO. 320216. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED PHOTO AND NO ISSUES WERE OBSERVED. AS NO SAMPLE WAS RETURNED FOR INVESTIGATION A CLOGGED NEEDLE CANNOT BE CONFIRMED. 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 PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. INVESTIGATION CONCLUSION: NO ISSUES WERE OBSERVED WITH THE RETURNED PHOTO THEREFORE NO ROOT CAUSE CAN BE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 · 1

    IT WAS REPORTED WITH THE USE OF THE BD MICRO-FINE¿ INSULIN PEN NEEDLE THERE WAS AN ISSUE WITH FOREIGN MATTER. IT WAS STATED ¿A COMPLAINT WAS RECEIVED FROM (B)(6) WHEREBY THE CUSTOMER STATED THAT THE NEEDLE WAS BLOCKED. THE NEEDLE WAS INVESTIGATED AND THE BLOCKAGE WAS IDENTIFIED AS SILICONE.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378204 BD MICRO-FINE¿ INSULIN PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON AND CO. 6173511

    Patients

    Seq Age Sex Outcome Treatment
    1 Other