BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSULIN PEN NEEDLE

    MDR report key: 7495181 · Received May 8, 2018

    Report

    Report Number
    9616656-2018-00098
    Event Type
    Malfunction
    Date Received
    May 8, 2018
    Date of Event
    April 17, 2018
    Report Date
    August 24, 2018
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K131358
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE OPENED 31G X 5MM PEN NEEDLE SAMPLE WAS RETURNED FROM LOT. NO. 7052715, CAT. NO. 325104. MAGNIFIED INSPECTION WAS CARRIED OUT AND IT WAS OBSERVED THAT THE HUB POST WITH CANNULA WERE BROKEN AWAY FROM THE ROOF OF THE HUB AND THAT THE PATIENT END OF CANNULA WAS BROKEN. AN INDENTATION MARK ON THE POST WAS ALSO 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. THIS ISSUE OCCURRED DUE TO A JAM ON THE TRANSFER DIAL ON THE ASSEMBLY LINE CAUSING THE HUB TO BREAK. BASED ON AN EVALUATION OF SEVERITY AND OCCURRENCE IT WAS DETERMINED THAT NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 0

    CORRECTION: DUE TO AN IT ISSUE BEGINNING ON 7/3/2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: DEVICE RETURNED TO MANUFACTURE: YES.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD INSULIN PEN NEEDLE THERE WAS AN ISSUE WITH BROKEN PRODUCT. IT WAS STATED ¿THE INNER COVER BROKE THROUGH DURING THE INJECTION AND THE NEEDLE BROKE OFF. THE NON-PATIENT END OF THE CANNULA WAS BROKEN.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD INSULIN PEN NEEDLE THERE WAS AN ISSUE WITH BROKEN PRODUCT. IT WAS STATED ¿THE INNER COVER BROKE THROUGH DURING THE INJECTION AND THE NEEDLE BROKE OFF. THE NON-PATIENT END OF THE CANNULA WAS BROKEN.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    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 WITH THE USE OF THE BD INSULIN PEN NEEDLE THERE WAS AN ISSUE WITH BROKEN PRODUCT. IT WAS STATED ¿THE INNER COVER BROKE THROUGH DURING THE INJECTION AND THE NEEDLE BROKE OFF. THE NON-PATIENT END OF THE CANNULA WAS BROKEN.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335947 BD INSULIN PEN NEEDLE INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. 7052715

    Patients

    Seq Age Sex Outcome Treatment
    1 Other