BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    5 ML BD LUER-LOK SYRINGE STERILE, SINGLE USE

    MDR report key: 10485616 · Received September 2, 2020

    Report

    Report Number
    1213809-2020-00595
    Event Type
    Malfunction
    Date Received
    September 2, 2020
    Date of Event
    August 13, 2020
    Report Date
    August 17, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096467
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. (B)(4). INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. ALL STERILITY PARAMETERS FOR BATCH 9120951 WERE WITHIN THE REQUIRED SPECIFICATIONS WITH NO ISSUES REPORTED. THE BATCH WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. DHR REVIEW: RELEASE DATE: (B)(6) 2019. RELEASED QUANTITY WAS (B)(4). ALL STERILITY PARAMETERS WERE WITHIN THE REQUIRED SPECIFICATIONS WITH NO ISSUES REPORTED. BATCH 9120951 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. INVESTIGATION CONCLUSION: 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. ROOT CAUSE DESCRIPTION: NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED AND NO INDICATION OF A POTENTIAL STERILITY ISSUE WAS RECORDED DURING REVIEW. RATIONALE: SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED CORRECTIVE ACTIONS ARE NOT NECESSARY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 5 ML BD LUER-LOK¿ SYRINGE STERILE, SINGLE USE HAD STERILITY FAILURES. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 309646, BATCH NO. 9120951. IT WAS REPORTED THAT FINAL PRODUCT HAD STERILITY FAILURES. EVENT DESCRIPTION PER EMAIL STATES: WE RECENTLY HAD STERILITY TESTING FAILURES ON OUR FINAL PRODUCT AND ARE WORKING ON INVESTIGATING THE CAUSE FOR FAILURES. ALTHOUGH WE HAVE NOT IDENTIFIED A SPECIFIC CAUSE OR MATERIAL, I AM REACHING OUT TO ALL MANUFACTURERS OF THE STERILE PRODUCTS USED IN THE PRODUCTION OF THESE BATCHES TO SEE IF THERE HAD BEEN ANY CONCERNS OR COMPLAINTS FROM OTHER CUSTOMERS REGARDING THESE PRODUCT LOT NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    949961 5 ML BD LUER-LOK SYRINGE STERILE, SINGLE USE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309646 9120951 30382903096467

    Patients

    Seq Age Sex Outcome Treatment
    1 Other