BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL BNS

    MDR report key: 19250214 · Received May 6, 2024

    Report

    Report Number
    1911916-2024-00327
    Event Type
    Malfunction
    Date Received
    May 6, 2024
    Date of Event
    January 17, 2024
    Report Date
    May 7, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    50382903010313
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP. IT WAS REPORTED THERE IS AN UNKNOWN LIQUID IN THE BARREL. 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 SYRINGE BARREL WITH WHAT APPEARS TO BE DROPLETS OF LUBRICANT. THE LUBRICANT IS APPLIED TO THE INNER WALL OF THE SYRINGE BARREL AND SYRINGE RUBBER STOPPER. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTO. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301031, LOT 3023920. 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 ACTUAL PHYSICAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    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. MATERIALS#: 30103 BATCH#: 3023920. IT WAS REPORTED BY THE CUSTOMER THAT UNK LIQUID IN THE BARREL. RCC RECEIVED A COMPLAINT VIA EMAIL. ALCON RECEIVED THE BELOW COMPLAINTS THAT I AM NOTIFYING YOU OF. AT THIS TIME NO FURTHER ACTION IS BEING REQUESTED. AT THIS TIME THE PRODUCT HAS NOT BEEN RETURNED TO ALCON. PLEASE ACKNOWLEDGE RECEIPT OF THIS COMPLAINT QS PR ID QS SHORT DESC COMPONENT PART NUM MATERIAL/COMPONENT LOT 2404601 UNK LIQUID IN THE BARREL 301031 3023920. 2404675 UNK LIQUID IN THE BARREL 301031 3163883.

    Description of Event or Problem · 0

    MATERIALS#: 30103 BATCH#: 3023920 IT WAS REPORTED BY THE CUSTOMER THAT UNK LIQUID IN THE BARREL. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. ALCON RECEIVED THE BELOW COMPLAINTS THAT I AM NOTIFYING YOU OF. AT THIS TIME NO FURTHER ACTION IS BEING REQUESTED. PLEASE SEE ATTACHED PICTURE. AT THIS TIME THE PRODUCT HAS NOT BEEN RETURNED TO ALCON. PLEASE ACKNOWLEDGE RECEIPT OF THIS COMPLAINT QS PR ID QS SHORT DESC COMPONENT PART NUM MATERIAL/COMPONENT LOT 2404601 UNK LIQUID IN THE BARREL 301031 3023920 2404675 UNK LIQUID IN THE BARREL 301031 3163883.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    768012 SYRINGE 20ML LL BNS SYRINGE, PISTON FMF BECTON DICKINSON 3023920 50382903010313

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown