BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NOKOR¿ FILTER AND ADMIX NEEDLES

    MDR report key: 17866121 · Received October 3, 2023

    Report

    Report Number
    1911916-2023-00725
    Event Type
    Malfunction
    Date Received
    October 3, 2023
    Date of Event
    September 19, 2023
    Report Date
    October 11, 2023
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903052005
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6:INVESTIGATION SUMMARY T WAS REPORTED THE EXPIRATION DATE IS SLIGHTLY CUT OFF. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS PACKAGING BLISTERS WHERE THE EXPIRATION DATE IS AND THE BOTTOM PART OF THE EXPIRATION DATE IS SLIGHTLY MISSING. THIS IS CONSIDERED AN ACCEPTABLE IMPERFECTION. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED.A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER (B)(4), LOT 2172517. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED BUT CONSIDERED AN ACCEPTABLE IMPERFECTION. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NOKOR¿ FILTER AND ADMIX NEEDLES THE LABEL WAS NOT PERFECTLY LEGIBLE. THIS OCCURRED 6 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINT FOR THE 19G 1½ FILTER NEEDLE (BD# 305200) LOT # 2172517. THE EXPIRATION DATE IS SLIGHTLY CUT OFF. IVERIC CAN PROVIDE SAMPLES.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD NOKOR¿ FILTER AND ADMIX NEEDLES THE LABEL WAS NOT PERFECTLY LEGIBLE. THIS OCCURRED 6 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COMPLAINT FOR THE 19G 1½ FILTER NEEDLE (BD# 305200) LOT # 2172517. THE EXPIRATION DATE IS SLIGHTLY CUT OFF. IVERIC CAN PROVIDE SAMPLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1526082 BD NOKOR¿ FILTER AND ADMIX NEEDLES HYPODERMIC SINGLE LUMEN NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 2172517 30382903052005

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown