BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 5505250 · Received March 16, 2016

    Report

    Report Number
    1911916-2016-00003
    Event Type
    Injury
    Date Received
    March 16, 2016
    Date of Event
    February 8, 2016
    Report Date
    April 13, 2018
    Manufacturer
    BD MEDICAL (BD EAST) PHARMACEUTICAL SYSTEMS
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    A SECONDARY LOT # WAS OMITTED FROM THE INITIAL AND SUPPLEMENTAL MDRS. THE INFORMATION FOR THE 2ND LOT # IS AS FOLLOWS: MEDICAL DEVICE LOT #: 4181650. MEDICAL DEVICE EXPIRATION DATE: 8/31/2019. DEVICE MANUFACTURE DATE: 6/1/2014. DHR REVIEW: BATCH 4181650 HAD SEVEN VISUAL INSPECTIONS PERFORMED ON 420 PARTS WITH ZERO DEFECTS NOTED. CLEANING WAS PERFORMED ONCE DURING THE PRODUCTION OF THIS ORDER. THERE WERE NO STERILIZATION ISSUES. ASSEMBLY BATCH 4181680 HAD 77 VISUAL INSPECTIONS PERFORMED ON 4,000 PARTS WITH ZERO DEFECTS NOTED. CLEANING WAS PERFORMED TEN TIMES DURING THE PRODUCTION OF THIS BATCH. ALL CLEANING WAS PERFORMED (B)(4).

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: N/A. (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: AS PREVIOUSLY REPORTED, A SAMPLE WAS NOT RETURNED FOR EVALUATION. IN ADDITION TO THE DHR REVIEW THAT WAS PREVIOUSLY REPORTED, A STERILIZATION PROCESS REVIEW REVEALED NO IRREGULARITIES. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED AN INTRAOCULAR INFECTION FOLLOWING THE INITIAL ADMINISTRATION OF THE DRUG LUCENTIS. A 19 G X 1 1/2 IN. BD NOKOR FILTER NEEDLE WAS USED DURING THE ADMINISTRATION OF THE MEDICATION. THE PATIENT UNDERWENT A VITRECTOMY AND AN INJECTION OF ANTIBIOTICS AND A STEROID. IT WAS ALSO REPORTED THAT THE PATIENT'S VISUAL ACUITY HAS IMPROVED POST TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162155 19 G X 1 1/2 IN. BD NOKOR¿ FILTER NEEDLE FILTER NEEDLE FMI BD MEDICAL (BD EAST) PHARMACEUTICAL SYSTEMS 2241139

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention