BEUDAMED
    FDA Adverse Event Injury Summary report: N

    30 G X 1/2 IN. BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE

    MDR report key: 5505237 · Received March 16, 2016

    Report

    Report Number
    1911916-2016-00002
    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
    K021475
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY AND STERILIZATION RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 4003126. IN THE EVENT THAT NEW, CHANGED, OR CORRECTED INFORMATION IS OBTAINED, A SUPPLEMENTAL REPORT WILL BE FILED. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. A SAMPLE IS NOT AVAILABLE FOR EVALUATION.

    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. ADDITIONALLY, OUR QUALITY ENGINEER STATES THAT THE PRODUCT WAS STERILIZED PER SPECIFICATIONS WITH NO ISSUES RECORDED AND THAT INTRAOCULAR INFLAMMATION IS ONE OF THE DOCUMENTED SIDE EFFECTS FOR LUCENTIS.

    Additional Manufacturer Narrative · 1

    A SECONDARY LOT # WAS OMITTED FROM THE INITIAL AND SUPPLEMENTAL MDRS. THE INFORMATION FOR THE 2ND LOT # IS AS FOLLOWS: MEDICAL DEVICE LOT #: 4212569. MEDICAL DEVICE EXPIRATION DATE: 8/31/2019. DEVICE MANUFACTURE DATE: 7/1/2014. DHR REVIEW: BATCH 4212569 ¿ TWENTY-SEVEN VISUAL INSPECTIONS WERE PERFORMED ON 1,620 PARTS WITH ZERO DEFECTS NOTED. CLEANING WAS PERFORMED FIVE TIMES DURING THE PRODUCTION OF THIS BATCH. ASSEMBLY BATCH 4181738 HAD 79 VISUAL INSPECTIONS PERFORMED ON 4,100 PARTS WITH ZERO DEFECTS NOTED. CLEANING WAS PERFORMED 10 TIMES DURING THE PRODUCTION OF THIS BATCH. THERE WERE NO STERILIZATION ISSUES WITH EITHER BATCH.

    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 30 G X 1/2 IN. BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC 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
    160784 30 G X 1/2 IN. BD PRECISIONGLIDE¿ SPECIALTY USE STERILE HYPODERMIC NEEDLE HYPODERMIC NEEDLE FMI BD MEDICAL (BD EAST) PHARMACEUTICAL SYSTEMS 4003126

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention