BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BERLIN CHEMIE BERLIFINE® 31G X 8MM INSULIN PEN NEEDLE

    MDR report key: 5723181 · Received June 14, 2016

    Report

    Report Number
    9616656-2016-00037
    Event Type
    Injury
    Date Received
    June 14, 2016
    Date of Event
    May 23, 2016
    Report Date
    July 5, 2016
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K123300
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    RESULTS: (B)(4) SEALED REPRESENTATIVE SAMPLES FROM THE SAME LOT # WERE RETURNED FOR EVALUATION. A MICROSCOPIC INSPECTION REVEALED NO ABNORMALITIES. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5230037. A MANUFACTURING REVIEW FOR LINE 2 SHOWED NO MAINTENANCE DURING PRODUCTION OF THIS LOT WHICH COULD HAVE CONTRIBUTED TO THIS FAIL MODE. CONCLUSION: A ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS THE RETURNED SAMPLES DID NOT EXHIBIT ANY DEFECTS AND BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE. OUR QUALITY ENGINEER NOTES THAT THERE ARE TWO POTENTIAL CAUSES FOR NEEDLE BREAK OFF IN USE: IF THE USER INADVERTENTLY BENDS THE NEEDLE PRIOR TO USE AND ATTEMPTS TO RE-STRAIGHTEN THE CANNULA, THE CANNULA MAY WEAKEN AND CAN SUBSEQUENTLY BREAK. DURING ASSEMBLY OF PEN NEEDLES THE CANNULA CAN BECOME TRAPPED BETWEEN THE INNER SHIELD AND THE HUB, CAUSING THE CANNULA TO FOLD OVER. IF THE USER TRIES TO STRAIGHTEN THE CANNULA BACK BEFORE USE, THE CANNULA MAY WEAKEN AND CAN SUBSEQUENTLY BREAK UPON USE. ADDITIONALLY, CAPA # (B)(4) WAS OPENED TO ADDRESS "PATIENT END NEEDLE BROKEN" DURING USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BERLIN CHEMIE BERLIFINE® 31G X 8MM INSULIN PEN NEEDLE (A PRIVATE LABEL MANUFACTURED BY (B)(4)) BROKE OFF WHILE IN USE. PART OF THE NEEDLE REMAINED IN THE PATIENT'S AND WAS REMOVED WITH A SMALL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378799 BERLIN CHEMIE BERLIFINE® 31G X 8MM INSULIN PEN NEEDLE INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. 5230037

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention