BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ DISPOSABLE SYRINGE

    MDR report key: 7561858 · Received June 1, 2018

    Report

    Report Number
    1213809-2018-00333
    Event Type
    Malfunction
    Date Received
    June 1, 2018
    Date of Event
    May 1, 2018
    Report Date
    June 5, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A BAG CONTAINING FOUR LOOSE 1ML SYRINGES AND NINE SEALED PACKAGED 1ML SYRINGES WERE RECEIVED, CONFIRMED TO BE FROM BATCH # 7240908 (P/N 309628). THE SAMPLES WERE VISUALLY EVALUATED. THE FOUR LOOSE SYRINGES WERE LINKED AT THE LUER BY AN ADAPTER MAKING 2 PAIRS. UNIDENTIFIED WHITE AND TRANSPARENT FLUID WAS FOUND IN THESE SYRINGES AND ADAPTER BETWEEN THEM. THE SYRINGES HAVE BEEN MANIPULATED PRIOR TO RETURN TO THE PLANT. NO VISUAL DEFECTS WERE OBSERVED. THESE SAMPLES COULD NOT BE FURTHER EVALUATED DUE TO CONTAMINATION RISK. THE NINE SEALED SAMPLES WERE OPENED AND TESTED FOR ASPIRATION ABILITY USING WATER. NO ISSUES WERE OBSERVED DURING THE TESTING. NO DEFECT FOUND IN THESE SAMPLES. PRODUCT DEFECT COULD NOT BE CONFIRMED BASED ON THE SAMPLES RECEIVED. DHR REVIEW FOR BATCH 7240908 (P/N 309628): MANUFACTURING DATES: 09/22/2017 TO 09/23/2017. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7240908 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. THE REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. ROOT CAUSE AND CAPA NOT REQUIRED AS NO DEFECTS WERE CONFIRMED. 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.

    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 DURING USE A BD LUER-LOK¿ DISPOSABLE SYRINGE WAS FOUND WITH MULTIPLE ISSUES AS"THE SERUM DOES NOT GO THROUGH NO MATTER WHAT SIZE NEEDLE IS USED. IN ADDITION, THE PLASTIC ON END CRACKED WHILE TRYING TO PUSH SERUM THROUGH." THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403705 BD LUER-LOK¿ DISPOSABLE SYRINGE HYPODERMIC SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 7240908 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other