BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL TIP 1ML

    MDR report key: 20544003 · Received October 28, 2024

    Report

    Report Number
    1911916-2024-00760
    Event Type
    Malfunction
    Date Received
    October 28, 2024
    Date of Event
    October 23, 2024
    Report Date
    November 4, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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

    (B)(4) FOLLOW UP: IT WAS REPORTED THE SYRINGE LEAKED BACKWARDS PAST THE PLUNGER. 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 AN EMPTY SYRINGE WITH THE STOPPER ALL THE WAY DOWN WITH AN OPENED PACKAGING BLISTER. THERE IS A WHITE COLORED SOLUTION BETWEEN THE STOPPER RIBS AND A DROPLET OF SOLUTION PAST THE RUBBER STOPPER. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTOS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT 4243285. 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.

    Description of Event or Problem · 0

    MATERIAL # 309653; BATCH # 4243285. IT WAS REPORTED BY CUSTOMER THAT SYRINGE LEAKED BACKWARDS PAST THE PLUNGER AND OUT THE TOP OF THE BARREL. NO PATIENT HARM.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED. WHEN WAS THIS DEFECT OBSERVED? DURING OR BEFORE USE? DURING USE. WHAT WAS THE IMPACT TO THE PATIENT? NONE. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1019858 SYRINGE 50ML LL TIP 1ML SYRINGE, PISTON FMF BECTON DICKINSON 4243285 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown