BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 21653942 · Received March 20, 2025

    Report

    Report Number
    1213809-2025-00212
    Event Type
    Malfunction
    Date Received
    March 20, 2025
    Date of Event
    March 4, 2025
    Report Date
    April 11, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    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

    (B)(6) - SUPPLEMENTAL MDR - FOREIGN MATTER ONE SAMPLE AND THREE PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE SAMPLE RECEIVED WITH THE UNSEALED PACKAGE HAS DISCOLORATION ON THE BARREL FLANGE; THIS IS CONSISTENT WITH EMBEDDED FOREIGN MATTER. ONE PHOTO SHOWS THE TOP WEB SIDE OF THE PACKAGE WITH ALL APPLICABLE PRODUCT INFORMATION AND THE NEXT TWO IMAGES FROM DIFFERENT ANGLES EACH SHOW THE ONE SYRINGE WITH THE DISCOLORATION ON THE BARREL. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE EMBEDDED FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS. THE EMBEDDED FOREIGN MATER IS MOST LIKELY DEGRADED PLASTIC. THIS OCCURS WHEN THE RESIN IS EXPOSED TO PROLONGED HIGH TEMPERATURES INSIDE THE MOLDING MACHINE, SUCH AS DURING START-UP. THIS TYPE OF DEFECT IS COSMETIC AND DOES NOT POSE A RISK TO THE CUSTOMER. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 4143437. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT, WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 4143437 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. 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.

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    MATERIALS: 309657. BATCH#: 4143437. IT WAS REPORTED THAT THE BD LUER-LOK HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. CHC COMPLAINT REFERENCE #: (B)(4) HOSPITAL COMPLAINT REFERENCE #: (B)(4) (B)(6). CORRESPONDENCE LANGUAGE: ENGLISH. CAT# OF PRODUCT BEING COMPLAINED: BD309657. DESCRIPTION OF PRODUCT: SYRINGE LL TIP ST 3CC 200EA/BX 4BX/CA. LOT OR S/N: (B)(6). COMPLAINT CATEGORY: FOREIGN MATTER / MATERIAL / DIRTY. RGA NUMBER: REPORTABLE: NO. INCIDENT DATE: (B)(6) 1980. HOSPITAL COMPLAINT REFERENCE #: (B)(4) DETAILS OF COMPLAINT (REPORTED ISSUE): "BROWN RESIDUE FOUND ON SYRINGE. WRAPPING WAS OPENED, THE SYRINGE WAS NOT USED." PLEASE NOTE: INCIDENT DATE IS. ADDITIONAL INFORMATION AND PHOTOS WILL BE SENT VIA SEPARATE EMAIL. COMPLAINT NOTICED: PRIOR TO USE. PROBLEM FREQUENCY: 1ST TIME. CUSTOMER EXPOSURE: PATIENT INJURY: NO. HAS HEALTH CANADA BEEN INFORMED? UNKNOWN. QTY AFFECTED: (B)(4) SAMPLES AVAILABLE? YES. IS CUSTOMER REQUESTING AN RGA? YES. ADDITIONAL INFORMATION PROVIDED: THE MESSAGE MEANS THAT THE TECHNICIAN OPENED THE PACKAGING TO USE THE PRODUCT WHEN THE BROWN STAIN WAS OBSERVED. THEY COULD NOT OBSERVE THE STAIN UNTIL PACKAGE WAS OPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537695 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4143437

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown