BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 25069301 · Received May 4, 2026

    Report

    Report Number
    1213809-2026-00233
    Event Type
    Malfunction
    Date Received
    May 4, 2026
    Date of Event
    April 9, 2026
    Report Date
    April 15, 2026
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 3ML LL 200 S/C BARREL CRACKED. COMPLAINT VIA EMAIL. INCIDENT OR PROBLEM INFORMATION. ALBERTA MDIP REFERENCE NUMBER (ID) (B)(4). DATE OF INCIDENT (YYYY-MM-DD): ON (B)(6) 2026. TYPE OF INCIDENT/PROBLEM A1. DEFECT (OBSERVED PRIOR TO USE). LEVEL OF HARM HAZARD. ALBERTA OPTIONAL REPORT TO CMDSNET (HEALTH CANADA). INCIDENT DETAILS NURSE WAS INJECTING SW INTO THE CATHFLO VIAL TO RECONSTITUTE THE MEDICATION. WHEN THE NURSE DEPRESSED THE PLUNGER, SW SPRAYED OUT FROM THE SIDE OF THE SYRINGE. UPON INSPECTION OF THE SYRINGE, A CRACK APPROXIMATELY 1 INCH IN LENGTH NOTED LENGTH WISE ON THE SYRINGE. AS THERE WAS SOME SW IN THE VIAL, BUT SOME HAD ALSO SPRAYED OUT, NURSE WAS UNSURE EXACTLY HOW MUCH WAS IN THE VIAL, AND THE VIAL OF CATHFLO HAD TO BE WASTED. DEVICE INFORMATION. DEVICE NAME/DESCRIPTION SYRINGE LUER LOCK TIP 3ML. MANUFACTURE BECTON DICKINSON CANADA INC. MANUFACTURER CODE/MODEL 309657. SERIAL OR LOT NUMBER UNKNOWN. SUPPLIER (B)(4), SUPPLIER/CATALOGUE NUMBER 308-309657. IS THE DEVICE RETAINED? YES. NUMBER OF DEVICES 1. WIPED, CONTAINED, LABELLED? DEVICE WAS CLEAN OR NOT USED. INVESTIGATION REQUEST. EXPECTED TYPE OF INVESTIGATION: ACTUAL DEVICE TESTED. E-MAIL ADDRESS FOR PERSON HOLDING DEVICE. SITE SHIPPING ADDRESS. CLINICAL CONTACT INFORMATION. PRIMARY CLINICAL CONTACT (CC ON FINAL REPORT). MANAGER (CC ON FINAL REPORT). MDIP FILING REFERENCE ID (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390936 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1