BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 30X1/2 RB

    MDR report key: 21051426 · Received January 1, 2025

    Report

    Report Number
    1911916-2024-00966
    Event Type
    Malfunction
    Date Received
    January 1, 2025
    Date of Event
    December 13, 2024
    Report Date
    January 20, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051060
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. BATCH: 2299220 BATCH CREATION DATE: 2022-10-26 BATCH EXPIRATION DATE: 2027-11-30 FULL UDI: (B)(4). BATCH: 2020895 BATCH CREATION DATE: 2022-01-20 BATCH EXPIRATION DATE: 2027-03-31 FULL UDI: (B)(4). BATCH: 3083951 BATCH CREATION DATE: 2023-03-24 BATCH EXPIRATION DATE: 2028-04-30 FULL UDI: (B)(4). BATCH: 3144657 BATCH CREATION DATE: 2023-05-24 BATCH EXPIRATION DATE: 2028-07-31 FULL UDI: (B)(4). BATCH: 3209276 BATCH CREATION DATE: 2023-07-28 BATCH EXPIRATION DATE: 2028-09-30 FULL UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). IT WAS REPORTED A WHITE MATERIAL MELTED ONTO THE PINK PART OF THE NEEDLE. TO AID IN THE INVESTIGATION, TWO PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTOS SHOW A NEEDLE ASSEMBLY WITH NO PACKAGING BLISTER OR PLASTIC SHIELD. THE NEEDLE HUB HAS AN EPOXY DRIP OVER. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS DEFECT COULD OCCUR IF THERE WAS JAM AT THE CANNULATOR. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305106, LOTS 2299220, 2020895, 3083951, 3144657 AND 3209276. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THESE LOTS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. VERIFICATION OF THE CANNULATOR WAS PERFORMED. THE SETTINGS WERE CORRECT, AND THE FLOW OF PRODUCT WAS GOOD. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Description of Event or Problem · 0

    MATERIAL # 305106. BATCH # 2299220, 2020895, 3083951, 3144657, 3209276. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. ON (B)(6)2024, REGENERON WAS INFORMED OF AN EVENT WITH EYLEA 8MG VIAL KIT WHICH WAS CATEGORIZED WITH THE DEFECT COMPONENT ISSUE CI-PHYSICAL ON (B)(6)2024, THE FOLLOWING EVENT OCCURRED BY HCP: ¿THE TECH WAS PREPPING AN EYLEA HD INJECTION AND WHEN OPENING THE INCLUDED NEEDLE, THEY NOTICED IT TO BE DAMAGED¿IT LOOKED LIKE SOME SORT OF WHITE ¿PLASTIC-LIKE¿ MATERIAL GOT MELTED ONTO THE PINK PART OF THE NEEDLE.¿

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254948 NEEDLE 30X1/2 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 3209276 30382903051060

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown