BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THE BD ULTRA-FINE¿ SHORT PEN NEEDLE IS 31 GAUGE, 8 MM (5/16")

    MDR report key: 6907630 · Received October 2, 2017

    Report

    Report Number
    9616656-2017-00104
    Event Type
    Malfunction
    Date Received
    October 2, 2017
    Date of Event
    June 9, 2017
    Report Date
    June 1, 2018
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: A SAMPLE HAS NOT BEEN RETURNED FOR EVALUATION. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCE'S WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. UPON COMPLETION OF THE INVESTIGATION, A SECOND SUPPLEMENTAL MDR WILL BE FILED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: SAMPLES HAVE BEEN RECEIVED FOR EVALUATION. INVESTIGATION SUMMARY: 91 SEALED AND INTACT AND 2 OPEN 31G X 8MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT NO. 6202727, CAT. NO. 320792. VISUAL EXAMINATION WAS CARRIED OUT ON THE OPEN SAMPLES AND IT WAS OBSERVED THAT ONE OF THE SAMPLES WAS BROKEN AT THE PATIENT END. NO INDENTATION ON THE HUB OR SHIELD WAS OBSERVED. NO ISSUES WERE OBSERVED ON THE SECOND OPENED SAMPLE. 30 SEALED AND INTACT SAMPLES WERE VISUALLY EXAMINED AND NO ISSUES WERE OBSERVED. NO MANUFACTURING RELATED ISSUES WERE OBSERVED WITH THE RETURNED SAMPLES. BASED ON AN EVALUATION OF SEVERITY AND FREQUENCY IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE THE BD ULTRA-FINE¿ SHORT PEN NEEDLE IS 31 GAUGE, 8 MM (5/16") ARE FRAGILE AND THE NEEDLE BROKE OFF AFTER THE INJECTION. FOUND DURING USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    687229 THE BD ULTRA-FINE¿ SHORT PEN NEEDLE IS 31 GAUGE, 8 MM (5/16") INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. 6202727

    Patients

    Seq Age Sex Outcome Treatment
    1 Other