BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL BNS

    MDR report key: 21510267 · Received March 3, 2025

    Report

    Report Number
    1213809-2025-00156
    Event Type
    Malfunction
    Date Received
    March 3, 2025
    Date of Event
    January 27, 2025
    Report Date
    April 7, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 - STOPPER JAMMED /INSECURE. ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON PHOTO EVALUATION, IT WAS OBSERVED THAT THE SAMPLE HAS STOPPER JAMMED BETWEEN THE BARREL AND THE PLUNGER ROD CONSISTENT WITH A DISTORTED STOPPER. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE STOPPER JAMMED DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 4243177. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 4243177 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.

    Description of Event or Problem · 0

    MATERIAL#: 301029 BATCH#: 4243177 IT WAS REPORTED THAT THE BD SYRINGE 10ML LL BNS STOPPER WAS JAMMED / INSECURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT DEFECTIVE 10CC SYRINGE (FLANGED). VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. RE: 2025-01-27-1/DEFECTIVE 10CC SYRINGE THIS LETTER IS TO INFORM YOU OF A COMPLAINT RECEIVED FROM ONE OF OUR CUSTOMERS REGARDING THE # 301029 (SYRINGE 10CC L/L) USED IN THE MANUFACTURE OF ONE OF OUR KITS. THE LOT NUMBER OF THE # 301029 USED IN THE KIT MANUFACTURED WAS (B)(4). XX PRIDES ITSELF IN PROVIDING QUALITY PRODUCTS TO OUR CUSTOMERS. ONE OF THE WAYS WE DO THIS IS BY PURCHASING QUALITY COMPONENTS TO BE USED IN OUR CUSTOM CONVENIENCE KITS. WHEN WE RECEIVE A CUSTOMER COMPLAINT, WE TAKE IT VERY SERIOUSLY AS WE KNOW YOU DO. PLEASE REFERENCE COMPLAINT (B)(4) WHEN PROVIDING ANY INFORMATION REGARDING THE MENTIONED LOT, THE RESULTS OF YOUR INVESTIGATION AND ANY CORRECTIVE/PREVENTIVE ACTIONS. ADDITIONAL INFORMATION PROVIDED: 1. WHAT IS THE DATE OF EVENT? (B)(6) 2025 2. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO PATIENT HARM, INJURY, OR NEGATIVE OUTCOME REPORTED. 4. ANY SAMPLE AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? NO SAMPLE AVAILABLE. DISCARDED AFTER PHOTOS TAKEN.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1345556 BD SYRINGE 10ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4243177

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown