BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1-1/2 RB

    MDR report key: 20902377 · Received December 11, 2024

    Report

    Report Number
    1911916-2024-00884
    Event Type
    Malfunction
    Date Received
    December 11, 2024
    Date of Event
    November 15, 2024
    Report Date
    January 16, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051961
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THERE IS AN INCREASED AMOUNT OF NEEDLE CORING. TO AID IN THE INVESTIGATION, TWENTY SAMPLES IN SEALED PACKAGING BLISTERS AND FOUR PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED TO THE SAMPLES RETURNED WITH 30X MAGNIFICATION. THERE WAS NO DAMAGE, DEFECTIVE GRIND OR HOOKS OBSERVED. THE BEVELS AND ETCH WERE GOOD. THE FOUR PHOTOS PROVIDED SHOW PACKAGING BLISTER TOP WEBS AND SYRINGES WITH A DARK COLORED SPECK IN THE SOLUTION. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTOS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305196, LOTS 4093946 AND 3236138. 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. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THESE LOTS. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED.

    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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Description of Event or Problem · 0

    MATERIAL#: 305196, BATCH NUMBER#: 4093946, 3236138. TO DATE, THERE HAVE BEEN NO KNOWN INCIDENTS INVOLVING PATIENT HARM OR INJECTION OF PARTICULATE DURING PATIENT CARE. ALL EVENTS WERE IDENTIFIED PRIOR TO INJECTION AND DISCARDED IMMEDIATELY. VERBATIM: IT WAS REPORTED BY CUSTOMER THAT AN INCREASE AMOUNT OF NEEDLE CORING OF FOREIGN MATTER. 2 SEPARATE LOT NUMBERS IDENTIFIED FOR MORE THAN 2 OCCURRENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2596693 NEEDLE 18X1-1/2 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 4093946 30382903051961

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown