BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1-1/2 BLUNT FILL

    MDR report key: 21051859 · Received January 1, 2025

    Report

    Report Number
    1911916-2024-00969
    Event Type
    Malfunction
    Date Received
    January 1, 2025
    Date of Event
    November 25, 2024
    Report Date
    January 20, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    GAA
    UDI-DI
    30382903051800
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, 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

    PR 11339535 FOLLOW UP. IT WAS REPORTED THERE WAS CORING OF THE VIAL. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. TO AID IN THE INVESTIGATION, ONE PHOTO WAS PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. THE PHOTO SHOWS A NEEDLE ASSEMBLED TO A SYRINGE WITH A DARK COLORED SPECK INDICATED BY A RED ARROW. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305180, LOT 4082855. 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. WITHOUT THE PHYSICAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED. CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    MATERIAL#: 305180, BATCH NUMBER#: 4082855. VERBATIM#: WE HAD A BD BLUNT FILL NEEDLE 18G X 1 ½ TW (REF 305180), LOT 4082855 CORE A VIAL OF NORMAL SALINE (NDC: 0409-4888-02, MANUFACTURER: XX) ON 11/25/2024. THE NEEDLE ENTERED THE VIAL AT 90 DEGREES PER THE INSTRUCTIONS FOR USE. WE DO NOT HAVE THE NEEDLE TO SEND BACK. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. ADDITIONAL MEDICATION HAD TO BE USED BECAUSE THE FIRST VIAL WAS WASTED. THIS WAS CAUGHT PRIOR TO REACHING THE PATIENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1694580 NEEDLE 18X1-1/2 BLUNT FILL NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BECTON DICKINSON 4082855 30382903051800

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown