BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD MICRO-FINE¿ PEN NEEDLE 31G X 5MM BENELUX

    MDR report key: 5837932 · Received August 1, 2016

    Report

    Report Number
    9616656-2016-00046
    Event Type
    Injury
    Date Received
    August 1, 2016
    Date of Event
    April 14, 2016
    Report Date
    August 17, 2016
    Manufacturer
    BECTON DICKINSON AND CO.
    Product Code
    FMI
    PMA / PMN Number
    K131358
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. A QUALITY NOTIFICATION REVIEW WAS CONDUCTED AND NO QNS WERE RAISED FOR THIS DEFECT ON LOT # 3073492. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 3073492. A MANUFACTURING REVIEW SHOWED NO MAINTENANCE ISSUES WHICH COULD HAVE INFLUENCED THIS FAILURE MODE DURING THE PRODUCTION OF THIS LOT #. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON THE EVENING OF (B)(6) 2016, THE PARENTS OF A (B)(6) FEMALE PATIENT INJECTED HER IN THE ABDOMEN WITH SOMATROPIN WHILE THE PATIENT WAS ASLEEP. DUE TO AN OUTBURST OF PAIN DURING THE INJECTION, THE NEEDLE FROM A BD MICRO-FINE¿ PEN NEEDLE 31G X 5MM BENELUX BROKE OFF AND REMAINED IN THE PATIENT'S INJECTION SITE. THE PATIENT WAS HOSPITALIZED IN A PEDIATRIC SURGERY WARD THAT SAME EVENING AND HAD SURGERY TO REMOVE THE BROKEN NEEDLE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE NEXT DAY. THIS INCIDENT OCCURRED IN ITALY BUT THE NAME AND ADDRESS OF WHERE THE INCIDENT OCCURRED WAS WITHHELD BY THE INITIAL REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488331 BD MICRO-FINE¿ PEN NEEDLE 31G X 5MM BENELUX INSULIN PEN NEEDLE FMI BECTON DICKINSON AND CO. 3073492

    Patients

    Seq Age Sex Outcome Treatment
    1 27 MO Hospitalization| R