BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    31 GX 8MM BD MICRO-FINE¿ INSULIN PEN NEEDLE

    MDR report key: 8340371 · Received February 14, 2019

    Report

    Report Number
    9616656-2019-00152
    Event Type
    Malfunction
    Date Received
    February 14, 2019
    Date of Event
    January 24, 2019
    Report Date
    March 1, 2019
    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
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: NINETY NINE SEALED AND ONE OPEN 31G X 8MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO. 8143576, CAT. NO. 320213. VISUAL EXAMINATION WAS CARRIED OUT ON THE OPENED SAMPLE AND A BENT PATIENT END OF CANNULA WAS OBSERVED. NO SHIELD WAS RETURNED AND NO INDENTATION ON THE HUB WAS OBSERVED. VISUAL EXAMINATION WAS ALSO CARRIED OUT ON THE TWENTY NINE SEALED SAMPLES AND NO ISSUES WERE 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 PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. NO MANUFACTURING RELATED ISSUES WERE OBSERVED ON THE RETURNED SAMPLES THEREFORE NO ROOT CAUSE CAN BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLE ON A 31G X 8MM BD MICRO-FINE¿ INSULIN PEN NEEDLE BROKE DURING INJECTION. IT WAS REPORTED THAT THE NEEDLE REMAINED IN THE PATIENT'S TISSUE AND NEEDED TO BE REMOVED. NO INFORMATION REGARDING MEDICAL INTERVENTION WAS REPORTED.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NEEDLE ON A 31G X 8MM BD MICRO-FINE¿ INSULIN PEN NEEDLE BROKE DURING INJECTION. IT WAS REPORTED THAT THE NEEDLE REMAINED IN THE PATIENT'S TISSUE AND NEEDED TO BE REMOVED. NO INFORMATION REGARDING MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134952 31 GX 8MM BD MICRO-FINE¿ INSULIN PEN NEEDLE PEN NEEDLE FMI BECTON DICKINSON AND CO. 8143576

    Patients

    Seq Age Sex Outcome Treatment
    1 Other