BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL S/C 200

    MDR report key: 18188672 · Received November 21, 2023

    Report

    Report Number
    1213809-2023-01328
    Event Type
    Malfunction
    Date Received
    November 21, 2023
    Date of Event
    October 27, 2023
    Report Date
    February 3, 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 9171607 - FOLLOW UP MDR FOR DEVICE EVALUATION. IT WAS REPORTED SOME 10ML SYRINGES ARE JUST BLANK. TO AID IN THE INVESTIGATION, THREE SAMPLES AND TWO PHOTOS OF A 10ML LUER LOK SYRINGE FROM LOT 3235306 WAS RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. TWO OF THE SAMPLES WERE RECEIVED IN SEALED PACKAGING BLISTERS AND ONE SAMPLE WAS LOOSE. ONE SYRINGE IN THE SEALED PACKAGING AND ONE LOOSE SYRINGE WERE MISSING ALL THE SCALE MARKINGS. ONE OF THE PHOTOS SHOWS TWO SEALED PACKAGES FROM THE TOP WEB WITH ALL APPLICABLE PRODUCT INFORMATION AND A LOOSE SYRINGE WITH ALL THE SCALE MARKINGS MISSING. THE SECOND IMAGE SHOWS THE LOOSE SYRINGE WITH THE TWO PACKAGED SYRINGES FROM THE BOTTOM WEB VIEW. THE LOOSE SYRINGE AND ONE PACKAGED SYRINGE ARE MISSING THE SCALE MARKING. THE OTHER PACKAGED SYRINGE HAS NO DEFECTS OBSERVED. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION AND IS ASSOCIATED WITH THE MARKING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 302995, LOT 3235306. THE REVIEW REVEALED ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. LOT 3235306 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN, SUBSEQUENTLY APPROVED FOR SHIPMENT AND IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. THIS CONDITION IS OCCURRING AT OR BELOW ITS EXPECTED FREQUENCY; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. 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.

    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 HAD A SCALE MARKING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SOME BD 10 ML SYRINGE (LUER-LOK TIP) DO NOT HAVE VOLUMES LISTED (ML) ON THE TUBE (SYRINGE). THEY ARE JUST BLANK." COMPLAINT NOTICED: DURING / AFTER USE PROBLEM FREQUENCY: 1ST TIME CUSTOMER EXPOSURE: PATIENT INJURY: NO HAS HEALTH CANADA BEEN INFORMED? YES QTY AFFECTED: 1 CA SAMPLES AVAILABLE? NO IS CUSTOMER REQUESTING AN RGA?: NO

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918225 BD SYRINGE 10ML LL S/C 200 PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3235306 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown