BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUER-LOK PRECISIONGLIDE

    MDR report key: 22716301 · Received August 5, 2025

    Report

    Report Number
    1213809-2025-00522
    Event Type
    Malfunction
    Date Received
    August 5, 2025
    Date of Event
    June 20, 2025
    Report Date
    August 22, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096329
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4). - SUPPLEMENTAL MDR - LUER CRACKED /DAMAGED/DEFORMED 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. 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 5ML LL W/NDL 21X1 RB LUER WAS CRACKED /DAMAGED /DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #:309632 BATCH#:5063045. RCC RECEIVED A COMPLAINT VIA EMAIL. " ON FRIDAY, (B)(6) 2025, A DOSE CONTAMINATION INCIDENT WAS REPORTED AT THE XXXXXXXXXXXXXXXXX. THE CONTAMINATION OCCURRED DUE TO A BROKEN SYRINGE, WHICH COMPROMISED THE CONNECTION AND CAUSED THE DOSE TO SPRAY UNEXPECTEDLY. AS A RESULT, THE PATIENT, STAFF, AND ROOM WERE CONTAMINATED. THE PATIENT WAS CLEANED, AND THE SITE RECEIVED A REPLACEMENT DOSE. THE PATIENT LATER RETURNED THE SAME DAY TO RECEIVE THE REPLACEMENT DOSE. THE ROOT CAUSE OF THIS ISSUE WAS THAT THE SYRINGE THAT WAS MISSING THE INNER PORTION OF THE MALE SLIP TIP. THIS MAY HAVE BROKEN OFF IN THE LUER CAP, OR HAVE BEEN MISSING DURING. DISPENSING." ITEM# 309632 LOT# 5063045.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2633657 LUER-LOK PRECISIONGLIDE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5063045 00382903096329

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown