BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ BLUNT PLASTIC CANNULA

    MDR report key: 7494958 · Received May 8, 2018

    Report

    Report Number
    1213809-2018-00273
    Event Type
    Malfunction
    Date Received
    May 8, 2018
    Date of Event
    April 23, 2018
    Report Date
    May 17, 2018
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    00382903033461
    PMA / PMN Number
    K974363
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A SINGLE LOOSE ASSEMBLED 3ML SYRINGE AND AN OPENED 3ML PACKAGE WERE RECEIVED, CONFIRMED TO BE FROM BATCH # 7237816 (P/N 303346). THE SAMPLE WAS VISUALLY EVALUATED. THE SYRINGE WAS FOUND TO HAVE GREEN GREASE FOREIGN MATTER LOCATED AT BARREL COLLAR OUTSIDE OF FLUID PATH. THE SIZE OF THE FOREIGN MATTER WAS GREATER THAN LEVEL 3, WHICH IS A REJECTABLE CONDITION. NO OTHER DEFECT WAS OBSERVED. DHR REVIEW FOR BATCH # 7237816 (P/N 3033746): MANUFACTURING DATES: 8/26/2018 ¿ 6/28/2017. BATCH QUANTITY WAS (B)(4) PIECES. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 7237816 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 BASED ON SEVERITY AND OCCURRENCE LEVEL DEFINED FOR THIS COMPLAINT. 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

    MEDICAL DEVICE EXPIRATION DATE: N/A. 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 WITH THE USE OF THE BD¿ BLUNT PLASTIC CANNULA THERE WAS AN ISSUE WITH FOREIGN MATTER. IT WAS STATED ¿A FUZZ OF STRING WAS FOUND INSIDE THE HUB OF THE SYRINGE.¿ THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336097 BD¿ BLUNT PLASTIC CANNULA HYPODERMIC NEEDLE FMI BECTON DICKINSON MEDICAL SYSTEMS 7237816 00382903033461

    Patients

    Seq Age Sex Outcome Treatment
    1 Other