BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY

    MDR report key: 7492897 · Received May 7, 2018

    Report

    Report Number
    1213809-2018-00263
    Event Type
    Malfunction
    Date Received
    May 7, 2018
    Date of Event
    April 17, 2018
    Report Date
    June 5, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096053
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8001674, MEDICAL DEVICE EXPIRATION DATE: 12/31/2022, DEVICE MANUFACTURE DATE: 02/05/2018. MEDICAL DEVICE LOT #: 7086600, MEDICAL DEVICE EXPIRATION DATE: 03/31/2022, DEVICE MANUFACTURE DATE: 06/05/2017. (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 · 1

    INVESTIGATION SUMMARY: NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION. WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. DHR REVIEW FOR BATCH 8001674 (P/N 309605): MANUFACTURING DATES: 01/27/2018 TO 1/28/2018. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 8001674 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. INVESTIGATION CONCLUSION: NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION. A ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY LEAKED. IT IS UNSPECIFIED WHEN THE LEAK WAS NOTICED. NO REPORTS OF SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335740 BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS SEE H.10. 00382903096053

    Patients

    Seq Age Sex Outcome Treatment
    1 Other