BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3ML LL W/NDL 18X1-1/2 BLUNT FILL

    MDR report key: 19959643 · Received August 12, 2024

    Report

    Report Number
    1213809-2024-00522
    Event Type
    Malfunction
    Date Received
    August 12, 2024
    Date of Event
    July 15, 2024
    Report Date
    July 19, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903050605
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E.1. ADDRESS WAS NOT LOCATED AND (B)(6) WAS USED. INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 3ML LL W/NDL 18X1-1/2 BLUNT FILL BARREL CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: ONE OF OUR INTERMOUNTAIN FACILITIES IS REPORTING AN ISSUE/CONCERN WITH AN ITEM THAT IT IS PURCHASED FROM YOUR COMPANY. SITUATION: ISSUE: PLASTIPAK 3ML SYRINGE BARREL CRACKED, BLOOD LEAKING DURING BLOOD DRAW. BACKGROUND: EVENT DATE: 7/15/2024. IH #: 93021798 MFG #: 305060 DESCRIPTION: SYRINGE 3ML 18GAX1.5 BLUNT FILL L/L TIP. SAMPLE AVAILABLE: NO SAMPLE OR PHOTOS ARE AVAILABLE FOR THIS EVENT. LOT #: 4031508 ASSESSMENT: CREDIT REQUESTED NO WAS THERE INJURY? NO NAME OF FACILITY : MAIN CONTACT NAME AND PHONE NUMBER: SELF. FRONTLINE CAREGIVERS CONTACT INFORMATION (IF APPLICABLE): NA ACCOUNT # PO PURCHASED ON: (B)(4). RECOMMENDATION/REQUEST: THERE IS NO SAMPLE OR PHOTO AVAILABLE FOR THIS EVENT, REPORTING PURPOSE ONLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1723974 BD SYRINGE 3ML LL W/NDL 18X1-1/2 BLUNT FILL PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4031508 30382903050605

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown