BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY

    MDR report key: 7071183 · Received November 30, 2017

    Report

    Report Number
    1213809-2017-00320
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Date of Event
    November 8, 2017
    Report Date
    February 22, 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
    VT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTION: DATE RECEIVED BY MANUFACTURER WAS REPORTED INCORRECTLY. THE CORRECT DATE RECEIVED BY MANUFACTURER IS 11/07/2017.

    Additional Manufacturer Narrative · 1

    RESULTS: BD RECEIVED EIGHTEEN (18) LOOSE 10ML ASSEMBLED SYRINGES, FILLED TO THE 7ML WITH A CLEAR LIQUID, WERE RECEIVED BY BD AND REPORTED TO BE FROM BATCH #7150981. THE SAMPLES WERE VISUALLY EVALUATED. THE SYRINGES WERE FOUND TO HAVE UNIDENTIFIED FLOATING PARTICLES CONTAINED IN THE FLUID. THESE PARTICLES APPEARED TO BE LEVEL ONE OR SMALLER, WHICH IS AN ACCEPTABLE CONDITION PER PRODUCT SPECIFICATION. IT IS NOT CLEAR WHETHER THE FM WAS GENERATED DURING THE SYRINGE MANUFACTURING PROCESS OR THE SYRINGE FILLING PROCESS. DHR REVIEW FOR BATCH 7150981 (P/N 309605): MANUFACTURING DATES: 6/16/2017 TO 6/17/2017. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7150981 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. BD WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE, HOWEVER THE DEFECT IS ACCEPTABLE PER PRODUCT SPECIFICATION. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. BASED ON THE SAMPLE EVALUATION: ¿ CONFIRMED: BD CANAAN WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE, HOWEVER THE DEFECT IS ACCEPTABLE PER PRODUCT SPECIFICATION. CONCLUSION: NO REJECTABLE DEFECTS CONFIRMED. BASED ON THE FACT THAT NO REJECTABLE DEFECT WAS FOUND, CAPA IS NOT REQUIRED AT THIS TIME.

    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 THE BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY HAD FOREIGN MATTER IN THE SYRINGES. FOUND BEFORE USE. NO SERIOUS INJURY OR MEDICAL INTERVENTION NOTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852971 BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7150981 00382903096053

    Patients

    Seq Age Sex Outcome Treatment
    1 Other