BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD DISCARDIT II¿ SYRINGE

    MDR report key: 15629168 · Received October 18, 2022

    Report

    Report Number
    2243072-2022-01782
    Event Type
    Malfunction
    Date Received
    October 18, 2022
    Date of Event
    September 22, 2022
    Report Date
    November 1, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS BAWAL. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1 AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. INITIAL REPORTER ADDR 1: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL? YES. D10: RETURNED TO MANUFACTURER ON: 01-NOV-2022. H6. INVESTIGATION SUMMARY: THE ONE SAMPLES AND TWO PHOTOS WERE RECEIVED BY BD FOR EVALUATION. A QUALITY ENGINEER WAS ABLE TO REVIEW THE PICTURES AND INSPECT THE RETURNED SAMPLES OF A 2 ML WITHOUT NEEDLE FOR THE REPORTED ISSUE OF WHITE PARTICLES IN THE SYRINGE FROM LOT NUMBER 1170868 PRODUCT NUMBER 300849. THE INVESTIGATING TEAM HAS ALSO USED THE RETENTION SAMPLES OF MATERIAL NUMBER 300849 AND LOT NUMBER 1170868 FOR INVESTIGATING THE REPORTED DEFECT. THE INVESTIGATION AND SIMULATION WERE CARRIED OUT ON TWO RETENTION SAMPLES WHERE THE INVESTIGATING TEAM HAS VISUALLY TESTED THE SAMPLES FOR WHITE PARTICLES IN SYRINGE AND NO WHITE PARTICLES IN SYRINGE WAS FOUND IN THE TWO RETENTION SAMPLES. THE INVESTIGATION WAS ALSO CARRIED OUT ON THE PHOTOGRAPH AS WELL. THE PHOTOGRAPH SHOWS THE REPORTED DEFECT OF WHITE PARTICLES IN THE SYRINGE. THERE WERE WHITE FLOATING PARTICLES FOUND INSIDE THE SYRINGE SENT BY THE CUSTOMER. THE DEFECT IS CONFIRMED. THE WHITE PARTICLE WAS TRACED BACK TO THE MOLDING PROCESS. THE CONNECTING CONVEYOR BELT BETWEEN MOLDING AND ASSEMBLY IS STOPPED AND MANUAL TRANSFER OF THE PRODUCTS HAS STARTED TO PREVENT THE WHITE PARTICLE FROM GETTING ACCUMULATED IN THE SYRINGES. THE DHR OF MATERIAL NO. 300849 WITH BATCH NO. 1170868 WAS CHECKED AND THERE WAS NO QUALITY NOTIFICATION FOUND ON THIS LOT NO. FROM ITS PRODUCTION DATE TO ITS DISPATCH ON DATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD DISCARDIT II¿ SYRINGE EXPERIENCED FOREIGN MATTER WITHIN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS PARTICULAR HOSPITAL CARRIES OUT EYE SURGERIES AND THE WHITE PARTICLES PRESENT IN THE SYRINGE HAS THE POTENTIAL TO HARM THE PATIENT. NO PATIENT HARM HAS BEEN REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD DISCARDIT II¿ SYRINGE EXPERIENCED FOREIGN MATTER WITHIN THE FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS PARTICULAR HOSPITAL CARRIES OUT EYE SURGERIES AND THE WHITE PARTICLES PRESENT IN THE SYRINGE HAS THE POTENTIAL TO HARM THE PATIENT. NO PATIENT HARM HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2944938 BD DISCARDIT II¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON 1170868

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown