BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL S/C 200

    MDR report key: 18179370 · Received November 20, 2023

    Report

    Report Number
    1213809-2023-01308
    Event Type
    Malfunction
    Date Received
    November 20, 2023
    Date of Event
    October 23, 2023
    Report Date
    March 13, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903029953
    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

    PR 9150359 ¿ FOLLOW UP MDR FOR DEVICE EVALUATION TWO PHOTOS OF A 10ML LUER-LOK SYRINGE WERE RECEIVED BY BD. A QUALITY ENGINEER WAS ABLE TO REVIEW THE PHOTOS FROM LOT #3213693 REGARDING ITEM #302995. BOTH IMAGES SHOW A LOOSE SYRINGE WITH THE STOPPER JAMMED BETWEEN THE BARREL AND THE PLUNGER ROD FROM DIFFERENT ANGLES, WITH ONE PHOTO ALSO CONTAINING THE TOP WEB GRAPHICS SIDE OF THE PACKAGE WITH ALL APPLICABLE PRODUCT INFORMATION. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE STOPPER JAMMED DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED BATCH NUMBER 3213693 SHOWING NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. 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. H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 10ML LL S/C 200 STOPPER WAS DEFECTIVE/DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE'RE REACHING OUT TO INFORM YOU THAT WE DISCOVERED ONE OF OUR SYRINGES WAS DEFECTIVE UPON OPENING. PLUNGER IS WARPED." RECEIVED ON 11/8/23: "THE STOPPER WAS FOUND DEFECTIVE, AND THE DATE OF THE EVENT IS 10/23/23." NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1855597 BD SYRINGE 10ML LL S/C 200 PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3213693 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown