BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 30ML LL S/C 56

    MDR report key: 21707295 · Received March 27, 2025

    Report

    Report Number
    1911916-2025-00245
    Event Type
    Malfunction
    Date Received
    March 27, 2025
    Date of Event
    March 20, 2025
    Report Date
    April 16, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903028321
    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)(6). FOLLOW UP FOR DEVICE EVALUATION: IT WAS REPORTED AN UNUSED 30ML SYRINGE WAS FOUND TO HAVE ABOUT 1ML OF A LIQUID IN IT. TO AID IN THE INVESTIGATION, TWO SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. ONE SAMPLE CAME IN A SEALED PACKAGING BLISTER AND ONE SAMPLE CAME WITH NO PACKAGING BLISTER. A VISUAL INSPECTION WAS PERFORMED. THE SAMPLE THAT CAME IN THE SEALED PACKAGING BLISTER HAS NO DEFECTS OR IMPERFECTIONS. THE SAMPLE RECEIVED WITH NO PACKAGING HAS AN EXCESS OF MEDICAL GRADE LUBRICANT. THE LUBRICANT IS APPLIED TO THE INNER WALL OF THE SYRINGE BARREL AND RUBBER STOPPER. THIS EXCESS LUBRICANT OCCURS IF THERE IS A JAM DURING THE PROCESS INDUCING THE EXTRA LUBRICANT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302832, LOT 5003597. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. THE SAMPLE WILL BE SHOWN TO ASSOCIATES FOR AWARENESS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION 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.

    Description of Event or Problem · 0

    MATERIAL#: 302832; BATCH#: 5003597. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED HELLO, WE HAVE FILED A COMPLAINT (B)(4) FOR YOUR ITEM 302832, LOT 5003597. CUSTOMER REPORTED ONE OF OUR UNUSED BD 30ML SYRINGES WAS FOUND TO HAVE ABOUT 1ML OF GEL/LIQUID IN IT TODAY. PLEASE PROVIDE US WITH A RMA FOR RETURNING THIS PRODUCT TO YOU OR IF YOU WILL JUST CREDIT. IF YOU NEED ADDITIONAL INFORMATION, PLEASE CONTACT US.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1407764 SYRINGE 30ML LL S/C 56 SYRINGE, PISTON FMF BECTON DICKINSON 5003597 30382903028321

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown