BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL NEEDLE

    MDR report key: 17901599 · Received October 9, 2023

    Report

    Report Number
    1911916-2023-00753
    Event Type
    Malfunction
    Date Received
    October 9, 2023
    Date of Event
    September 25, 2023
    Report Date
    October 12, 2023
    Manufacturer
    BECTON DICKINSON AND COMPANY
    Product Code
    FMI
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: IT WAS REPORTED THERE IS A VOID ON THE HUB. TO AID IN THE INVESTIGATION, FOUR PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTOS SHOW WHAT APPEARS TO BE A SURFACE WITH A VOID AT A MAGNIFICATION THAT COULD BE 1000X+, AND WHERE IMPERFECTIONS WILL MOST LIKELY BE VISIBLE. AT THE MANUFACTURING SITE, PARTS ARE INSPECTED WITH SINGLE DIGIT MAGNIFICATION. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301643, LOTS 0157500, 1111793 AND 1172758. 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 PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. HOWEVER, IS CONSIDERED AN IMPERFECTION. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 0157500. D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.4. DEVICE MANUFACTURE DATE: 06-MAY-2020. D.4. MEDICAL DEVICE LOT #: 1111793. D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.4. DEVICE MANUFACTURE DATE: 21-APR-2021. D.4. MEDICAL DEVICE LOT #: 1172758. D.4. MEDICAL DEVICE EXPIRATION DATE: NA. H.4. DEVICE MANUFACTURE DATE: 21-JUN-2021. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD CONVENTIONAL NEEDLE HUB WAS DAMAGED. 0157500, 1111793, 1172758. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER COMPLAINTS RECEIVED FOR VOID ON THE HUB.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD CONVENTIONAL NEEDLE HUB WAS DAMAGED. 0157500, 1111793, 1172758. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER COMPLAINTS RECEIVED FOR VOID ON THE HUB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2004115 BD CONVENTIONAL NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON AND COMPANY SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown