BEUDAMED
    FDA Adverse Event Injury Summary report: N

    19 G X 1 1/2 IN. BD NOKOR¿ FILTER NEEDLE

    MDR report key: 5995020 · Received October 3, 2016

    Report

    Report Number
    1911916-2016-00014
    Event Type
    Injury
    Date Received
    October 3, 2016
    Date of Event
    August 25, 2016
    Report Date
    October 26, 2016
    Manufacturer
    BD MEDICAL (BD EAST) PHARMACEUTICAL SYSTEMS
    Product Code
    GAA
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE INITIAL REPORTER ALSO INDICATED THIS INCIDENT WAS CONSIDERED TO BE A SERIOUS MEDICAL PRODUCT COMPLAINT, HOWEVER, THE INITIAL REPORTER WAS UNABLE TO PROVIDE ADDITIONAL INFORMATION DUE TO PATIENT CONFIDENTIALITY. THEREFORE, THIS INCIDENT WAS DETERMINED TO BE MDR REPORTABLE. THE BD ADVERSE EVENTS GROUP HAS DETERMINED THE CLAIM OF A ¿SERIOUS MEDICAL PRODUCT COMPLAINT¿ IMPLIES THAT MEDICAL INTERVENTION WAS PROVIDED. DEVICE EVALUATION: 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 # 4181639 AND THERE WERE NO ISSUES WITH SEALS OR STERILIZATION DURING THE MANUFACTURE OF THIS BATCH. 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.

    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 THAT A 19 G X 1 1/2 IN. BD NOKOR FILTER NEEDLE WAS ASSOCIATED WITH AN EVENT WHERE A PATIENT DEVELOPED ENDOPHTHALMITIS WHILE RECEIVING THE DRUG LUCENTIS. IT IS UNKNOWN IF ANY MEDICAL INTERVENTIONS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645260 19 G X 1 1/2 IN. BD NOKOR¿ FILTER NEEDLE FILTER NEEDLE GAA BD MEDICAL (BD EAST) PHARMACEUTICAL SYSTEMS 4181639

    Patients

    Seq Age Sex Outcome Treatment
    1 Other