BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ VACUTAINER¿ MULTI-SAMPLE NEEDLES

    MDR report key: 7351064 · Received March 19, 2018

    Report

    Report Number
    9617032-2018-00043
    Event Type
    Malfunction
    Date Received
    March 19, 2018
    Date of Event
    February 26, 2018
    Report Date
    March 22, 2018
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR FOREIGN MATTER ON THE IV CANNULA WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, EVALUATION/ OF THE CUSTOMER SAMPLES WAS PERFORMED AND SMALL PIECES OF BLACK PLASTIC ON THE IV NEEDLE WERE OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER PHOTOS AND SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR FOREIGN MATTER WITH THE INCIDENT LOT WAS OBSERVED. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, THE MOST LIKELY ROOT CAUSE WAS DETERMINED TO BE RELATED TO A MANUFACTURING ISSUE. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ADD¿L INFORMATION: LOT # PROVIDED: 7083838. MEDICAL DEVICE EXPIRATION DATE: 03/31/2022. DEVICE MANUFACTURE DATE: 03/24/2017.

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLACK FOREIGN MATTER WAS SEEN ON A BD¿ VACUTAINER¿ MULTI-SAMPLE NEEDLE BEFORE USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194040 BD¿ VACUTAINER¿ MULTI-SAMPLE NEEDLES SAMPLE NEEDLE FMI BECTON, DICKINSON AND COMPANY (BD) 7083838

    Patients

    Seq Age Sex Outcome Treatment
    1 Other