BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 5ML LL BNS

    MDR report key: 21546482 · Received March 7, 2025

    Report

    Report Number
    1213809-2025-00171
    Event Type
    Malfunction
    Date Received
    March 7, 2025
    Date of Event
    February 11, 2025
    Report Date
    April 1, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    NA
    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

    (B)(4) - SUPPLEMENTAL MDR - STOPPER JAMMED/INSECURE. ONE SAMPLE AND ONE PHOTO WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON EVALUATION, IT WAS OBSERVED THAT THE STOPPER DISTORTED AND JAMMED BETWEEN THE BARREL AND THE PLUNGER ROD. 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 4171418. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 4171418 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

    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

    MATERIAL # 301027. BATCH # 4171418. IT WAS REPORTED THAT THE BD SYRINGE 5ML LL BNS STOPPER WAS JAMMED / INSECURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. I WAS JUST PRESENTED WITH A 5ML BD SYRINGE (SAME LOT NUMBER AS 18 GA 1 ½ WITH BURR) THAT HAD A DEFECTIVE PLUNGER GASKET. WHEN THE PA ATTEMPTED TO PULL THE PLUNGER BACK TO FILL THE SYRINGE FROM A VIAL, THE GASKET ""ROLLED OVER"" THE LIP OF THE PLUNGER AND GOT STUCK (PHOTO ATTACHED). PLEASE SEND ANOTHER RETURN LABEL SO THAT I CAN SEND THIS ITEM BACK. ITEM -301027. LOT - 4171418.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593198 BD SYRINGE 5ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4171418

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown