BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGES WITH PRECISIONGLIDE NEEDLE & LUER-LOK TIP

    MDR report key: 7561826 · Received June 1, 2018

    Report

    Report Number
    1213809-2018-00327
    Event Type
    Malfunction
    Date Received
    June 1, 2018
    Date of Event
    April 27, 2018
    Report Date
    June 5, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903095712
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. DHR REVIEW FOR BATCH 8010874 (P/N 309701): MANUFACTURING DATES: 01/30/2018 TO 02/01/2018. BATCH QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 8010874 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. 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 SYRINGES WITH PRECISIONGLIDE NEEDLE & LUER-LOK TIP WAS FOUND WITH FOREIGN MATTER AS ¿A PIECE OF RUBBER WAS FOUND FLOATING IN THE SYRINGE AFTER DRAWING A DOSE OF RADIOPHARMACUETICAL." THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403221 BD SYRINGES WITH PRECISIONGLIDE NEEDLE & LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 8010874 30382903095712

    Patients

    Seq Age Sex Outcome Treatment
    1 Other