BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY

    MDR report key: 7850829 · Received September 6, 2018

    Report

    Report Number
    1213809-2018-00593
    Event Type
    Malfunction
    Date Received
    September 6, 2018
    Date of Event
    July 23, 2018
    Report Date
    September 17, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903097013
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE SEALED 1ML SYRINGE TRAY WAS RECEIVED AND CONFIRMED TO BE FROM BATCH #7299668 (P/N 309701). THE SAMPLE WAS VISUALLY EVALUATED. NO DEFECTS WERE OBSERVED. 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. THE SDA (STERILIZATION DOSE AUDIT) & BIOBURDEN TESTS FOR THE BULK CONVENIENCE PAK FAMILY TESTED DURING THIS TIMEFRAME (NOVEMBER 2017 REQUIREMENT) WERE REVIEWED. BOTH TESTS HAD ACCEPTABLE RESULTS. THERE WERE NO POSITIVES RECOVERED ON THE SDA TEST. IN ADDITION, THERE WERE NO POSITIVES RECOVERED FOR THE BULK CONVENIENCE PAK FAMILY ON SDA TESTING DURING 2017 OR 2018. TO ANSWER CUSTOMER¿S INQUIRY REGARDING MICROORGANISM USE AT BD: BACILLUS CEREUS IS NOT USED IN THE BD CANAAN MICRO LAB. THE ORGANISM WE MAINTAIN FOR GROWTH PROMOTION TESTING OF OUR MEDIA ARE: C. ALBICANS, B. SUBTILIS, A. BRASILIENSIS, C. SPOROGENES, P. AERUGINOSA, S. AUREUS. ROOT CAUSE NOT DEFINED SINCE DEFECTS WERE NOT CONFIRMED IN SAMPLES RECEIVED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BACILLUS CEREUS WAS FOUND ON THE BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY DURING STERILITY TESTING. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    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 BACILLUS CEREUS WAS FOUND ON THE BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY DURING STERILITY TESTING. THERE WAS NO REPORT OF EXPOSURE, INJURY, OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691971 BD LUER-LOK¿ SYRINGE BULK STERILE PHARMACY CONVENIENCE TRAY PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7299668 30382903097013

    Patients

    Seq Age Sex Outcome Treatment
    1 Other