BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE FILTER BLUNT FILL 18X1-1/2

    MDR report key: 19575960 · Received June 20, 2024

    Report

    Report Number
    1911916-2024-00444
    Event Type
    Malfunction
    Date Received
    June 20, 2024
    Date of Event
    June 17, 2024
    Report Date
    July 10, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    GAA
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 WAS A DUST-LIKE FOREIGN SUBSTANCE ON THE NEEDLE TIP. TO AID IN THE INVESTIGATION, ONE SAMPLE WITH NO PACKAGING BLISTER AND FIVE PHOTOS WERE PROVIDED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. FIRST, WITH 10X MAGNIFICATION, AND THEN WITH 30X MAGNIFICATION. THERE IS A PARTICLE 1/64" IN SIZE ADHERED TO THE NEEDLE TIP. THE APPEARANCE OF THE FOREIGN MATTER LOOKS LIKE THE LUBRICANT APPLIED TO THE OUTER SURFACE OF THE NEEDLE. DUE TO THE SIZE OF THE PARTICLE, FOURIER-TRANSFORM INFRARED SPECTROSCOPY (FTIR) COULD NOT BE PERFORMED. THE FIVE PHOTOS PROVIDED SHOW THE SAMPLE RECEIVED. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. IT COULD BE POSSIBLE, DURING THE LUBRICANT APPLICATION, A PARTICLE OF LUBRICANT BECAME ATTACHED TO THE NEEDLE TIP. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 30521104, POSSIBLE LOTS 1336506 OR 2060348. 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. BASED ON THE INVESTIGATION AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS 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. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED. IT WAS REPORTED THAT A DUST-LIKE FOREIGN SUBSTANCE ON THE NEEDLE TIP DURING USE. AS POSSIBLE LOT NUMBERS ARE 1336506 OR 2060348.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DUST-LIKE FOREIGN SUBSTANCE ON THE NEEDLE TIP DURING USE. AS POSSIBLE LOT NUMBERS ARE 1336506 OR 2060348.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1654989 NEEDLE FILTER BLUNT FILL 18X1-1/2 NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown