BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL BNS

    MDR report key: 18738843 · Received February 20, 2024

    Report

    Report Number
    1213809-2024-00094
    Event Type
    Malfunction
    Date Received
    February 20, 2024
    Date of Event
    July 25, 2023
    Report Date
    January 30, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    50382903010290
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THERE WERE BLACK MARKINGS AROUND THE SYRINGE. TO AID IN THE INVESTIGATION, FIVE LOOSE 10ML SYRINGES AND ONE PHOTO WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. THERE WAS A LARGE RING OF SMEARED INK NOTED AROUND THE BD LOGO AND WAS NEARLY IDENTICAL ON ALL THE SYRINGES. THE OBSERVED CONDITION IS NON-CONFORMING PER PRODUCT SPECIFICATION AND IS ASSOCIATED WITH THE SCALE MARKING PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301029, LOT 3122541. THE REVIEW REVEALED ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER APPLICABLE OPERATIONAL QUALITY SPECIFICATIONS. THERE WAS ONE QUALITY NOTIFICATION NOTED THAT PERTAINED TO THE INK RING COMPLAINT AND THE DEFECTIVE PRODUCT WAS SCRAPPED. THIS CONDITION IS OCCURRING AT OR BELOW ITS EXPECTED FREQUENCY; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. LOT 3122541 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. 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

    POST INVESTIGATION FINDINGS REVEAL THAT THE BD SYRINGE 10ML LL BNS HAD A SCALE MARKING ISSUE. IT WAS REPORTED BY THE CUSTOMER THAT HAS BLACK MARKINGS AROUND THE SYRINGE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED CUSTOMER REPORTED NON-CONFORMING PRODUCT FOUND IN OUR WAREHOUSE DURING PICKING PROCESS. PART # 301029, LOT # 3122541 HAS BLACK MARKINGS AROUND THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377483 BD SYRINGE 10ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3122541 50382903010290

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown