BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL TIP 1ML

    MDR report key: 20598116 · Received November 4, 2024

    Report

    Report Number
    1911916-2024-00787
    Event Type
    Malfunction
    Date Received
    November 4, 2024
    Date of Event
    October 5, 2024
    Report Date
    November 13, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903096535
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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 (B)(4). FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THERE IS A WHITE SPOT ON THE INSIDE OF THE SYRINGE. TO AID IN THE INVESTIGATION, ONE SAMPLE IN AN OPENED PACKAGING BLISTER WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. AT THE BOTTOM OF THE SYRINGE BARREL THERE IS A VOID THAT IS 3/32" X 1/8." NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. A VOID COULD OCCUR DURING THE MOLDING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309653, LOT 4183156. 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. 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 AND WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.

    Description of Event or Problem · 0

    MATERIAL#: 309653; BATCH#: 4183156. IT WAS REPORTED BY THE CUSTOMER THAT IV TECH FOUND SOMETHING ODD ON A 50ML BD IV SYRINGE -LOT# 4183156, EXPIRATION: 6/30/29. IT IS A WHITE SPOT ON THE INSIDE OF THE SYRINGE (NOT ON PLUNGER). LOOKS LIKE IT COULD BE SOMETHING OR JUST A PLASTIC ABNORMALITY. SENT PICTURES AND ESCALATED TO PEDIATRIC PHARMACY MOC. SEQUESTERED SYRINGE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED. 1 DID THE ISSUE HAPPEN DURING PATIENT USE. YES. 2 IF YES, WAS THERE ANY INJURY. NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631428 SYRINGE 50ML LL TIP 1ML SYRINGE, PISTON FMF BECTON DICKINSON 4183156 30382903096535

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown