BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MICRO-FINE¿ INSULIN PEN NEEDLE

    MDR report key: 7836892 · Received August 31, 2018

    Report

    Report Number
    9616656-2018-00184
    Event Type
    Malfunction
    Date Received
    August 31, 2018
    Date of Event
    August 10, 2018
    Report Date
    October 2, 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 HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE PHOTO OF A 29G X 1.7MM PEN NEEDLE WAS RETURNED FROM LOT. NO. 6173511, CAT. NO. 320216. VISUAL EXAMINATION WAS CARRIED OUT ON THE RETURNED PHOTO AND A HOOKED CANNULA WAS OBSERVED. NO FOREIGN MATTER WAS OBSERVED ON THE CANNULA. 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. THIS DAMAGE OCCURRED ON THE ASSEMBLY LINE PRIOR TO THE SHIELDING PROCESS. BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD MICRO-FINE¿ INSULIN PEN NEEDLE CONTAINED FOREIGN MATTER DESCRIBED AS "DRIED PRODUCT". NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(6). 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 BD MICRO-FINE¿ INSULIN PEN NEEDLE CONTAINED FOREIGN MATTER DESCRIBED AS "DRIED PRODUCT". NO SERIOUS INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681101 BD MICRO-FINE¿ INSULIN PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON AND CO. 6173511

    Patients

    Seq Age Sex Outcome Treatment
    1 Other