BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETY-LOK¿ SYRINGE WITH DETACHABLE NEEDLE

    MDR report key: 7559033 · Received May 31, 2018

    Report

    Report Number
    1213809-2018-00326
    Event Type
    Malfunction
    Date Received
    May 31, 2018
    Date of Event
    May 10, 2018
    Report Date
    June 5, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    30382903095927
    PMA / PMN Number
    K944757
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SAMPLE EVALUATION: A BAG CONTAINED TWO LOOSE 3ML SAFETYLOK SYRINGES WAS RECEIVED, REPORTED TO BE FROM BATCH # 7260819 (P/N 309592). THE SAMPLES WERE VISUALLY EVALUATED. INK SMEAR WAS OBSERVED ON BOTH SYRINGES ON FLANGE AND BARREL WALL OUTSIDE OF FLUID PATH. THE SIZE OF THE INK MARK WAS GREATER THAN LEVEL 3, WHICH IS REJECTABLE PER PRODUCT SPECIFICATION. PRODUCT DEFECT CONFIRMED BASED ON SAMPLE EVALUATION. DHR REVIEW FOR BATCH 7260819 (P/N 309592): MANUFACTURING DATES: 09/20/2017 TO 09/21/2017. BATCH QUANTITY WAS 216,000. PRINTING AND ASSEMBLY RECORDS WERE REVIEWED AS PART OF THIS DHR REVIEW. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7260819 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. INVESTIGATION CONCLUSION: PRODUCT DEFECT CONFIRMED BASED ON SAMPLE EVALUATION. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT OUT OF 2 BOXES, 15 BD SAFETY-LOK¿ SYRINGES WITH DETACHABLE NEEDLES WERE FOUND WITH FOREIGN MATTER "APPEARS TO BE INK OR PAINT SPOTS" INSIDE AND OUTSIDE OF THE BARREL. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398408 BD SAFETY-LOK¿ SYRINGE WITH DETACHABLE NEEDLE SYRINGE WITH HYPODERMIC NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 7260819 30382903095927

    Patients

    Seq Age Sex Outcome Treatment
    1 Other