BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK¿ TIP

    MDR report key: 7334483 · Received March 13, 2018

    Report

    Report Number
    1213809-2018-00163
    Event Type
    Malfunction
    Date Received
    March 13, 2018
    Date of Event
    March 6, 2018
    Report Date
    March 26, 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
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SAMPLE/PHOTO EVALUATION: FIVE PACKAGED SAMPLES AND ONE PHOTO RECEIVED AT BD CANAAN, CONFIRMED TO BE FROM BATCH # 7212606 (B)(4). A SAMPLE EVALUATION WAS PERFORMED. LOOSE FOREIGN MATTER APPEARS TO BE PROPYLENE PARTICLES ALONG WITH SILICONE OUTSIDE THE FLUID PATH. DHR REVIEW FOR BATCH 7212606(B)(4). MANUFACTURING DATE: 08/22/2017. BATCH QUANTITY WAS 504,000. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7212606 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. MACHINE # 66, NOTIFICATION N/A, ADJUSTMENTS N/A, REQUAL N/A. CONFIRMED: BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE INVESTIGATION CONCLUSION: ROOT CAUSE UNDETERMINED.

    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 BEFORE USE OF THE BD SYRINGE LUER-LOK¿ TIP THERE IS FOREIGN MATTER. CONSUMER STATES ¿THE SYRINGE HAS A DUST BUNNY INSIDE THE WRAPPER.¿ THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179418 BD SYRINGE LUER-LOK¿ TIP SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7212606 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 Other