BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 16X1 RB

    MDR report key: 20278233 · Received September 23, 2024

    Report

    Report Number
    1911916-2024-00688
    Event Type
    Malfunction
    Date Received
    September 23, 2024
    Date of Event
    September 7, 2024
    Report Date
    October 18, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051978
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THERE IS PARTICLE CONTAMINATION SEALED WITHIN THE PACKAGING AND NEEDLE HUB. TO AID IN THE INVESTIGATION, TWELVE SAMPLES IN SEALED PACKAGING BLISTERS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS, IMPERFECTIONS OR FOREIGN MATTER OF ANY KIND WAS OBSERVED. THE TWO PHOTOS PROVIDED SHOW SOME OF THE SAMPLES RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305197, LOT 4060205. 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 SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    MATERIAL #: 305197, BATCH#: 4060205. IT WAS REPORTED BY CUSTOMER THAT NEEDLES CONTAIN PARTICLE CONTAMINATION SEALED WITHIN THE PACKAGING AND INSIDE THE NEEDLE HUB. VERBATIM: COMPLAINT RECEIVED VIA EMAIL(S) ATTACHED. NEEDLES CONTAIN PARTICLE CONTAMINATION SEALED WITHIN THE PACKAGING AND INSIDE THE NEEDLE HUB.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED. MATERIAL #: 305197, BATCH#: 4060205. IT WAS REPORTED BY CUSTOMER THAT NEEDLES CONTAIN PARTICLE CONTAMINATION SEALED WITHIN THE PACKAGING AND INSIDE THE NEEDLE HUB. VERBATIM: COMPLAINT RECEIVED VIA EMAIL(S). NEEDLES CONTAIN PARTICLE CONTAMINATION SEALED WITHIN THE PACKAGING AND INSIDE THE NEEDLE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1488588 NEEDLE 16X1 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 4060205 30382903051978

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown