BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LUER-LOK¿ TIP

    MDR report key: 7073572 · Received November 30, 2017

    Report

    Report Number
    1213809-2017-00307
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Date of Event
    November 2, 2017
    Report Date
    February 5, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903029953
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DHR REVIEW FOR BATCH #7150625 (P/N 302995): MANUFACTURING DATES: 06/23/2017 TO 6/24/2017. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT. MISSING PRINT, SKEWED SCALE AND ROLLED SCALE WERE FOUND DURING PRODUCTION. A QUALITY NOTIFICATION WAS ISSUED FOR SKEWED SCALE DURING THE MANUFACTURE OF THIS BATCH. PRINTING PROCESS ADJUSTMENTS WERE PERFORMED TO ADDRESS THE ISSUES AND PRODUCT WAS REQUALIFIED PER APPLICABLE AQL. BATCH 7150625 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. SAMPLE EVALUATION: ONE OPEN 10ML PACKAGED SYRINGE AND THREE EMPTY PACKAGES WERE RECEIVED AT BD CANAAN PLANT AND CONFIRMED TO BE FROM BATCH #7150625 (P/N 302995). ONE PHOTO WAS ALSO SUBMITTED FOR EVALUATION. BASED ON THE VISUAL EVALUATION OF THE RETURNED SAMPLE AS WELL AS THE PHOTO, 10ML SYRINGE WAS FOUND TO HAVE SKEWED SCALE. THE PRINTED SCALE DOES NOT RUN STRAIGHT ALONG THE BARREL. 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. SKEWED SCALE IS MOST LIKELY A RESULT OF BARREL FEED ISSUE DURING THE PRINTING PROCESS WHICH WAS NOTED IN QUALITY NOTIFICATION STATED IN DHR REVIEW. BASED ON THE SEVERITY ASSIGNED TO THIS COMPLAINT AND THE RESULTS OF THE COMPLAINT LOT HISTORY CHECK, CAPA IS NOT REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE DEFECTIVE SCALE MARKINGS ON THE BD SYRINGE 10ML LUER-LOK¿ TIP. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852311 BD SYRINGE 10ML LUER-LOK¿ TIP SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7150625 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 Other