BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    19 G X 1 1/2 IN. BD NOKOR¿ FILTER NEEDLE

    MDR report key: 6860398 · Received September 12, 2017

    Report

    Report Number
    1911916-2017-00218
    Event Type
    Malfunction
    Date Received
    September 12, 2017
    Date of Event
    June 27, 2017
    Report Date
    October 6, 2017
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION: INVESTIGATION SUMMARY: WE WERE UNABLE TO CONDUCT AN INVESTIGATION AS NO SAMPLES OR PHOTOS WERE PROVIDED. DHR REVIEW: TEN VISUAL INSPECTIONS WERE PERFORMED ON 600 PARTS WITH ZERO DEFECT FOUND. CLEANING WAS PERFORMED TWICE DURING THE PACKAGING OF THIS BATCH. ASSEMBLY BATCH 6181735 HAD 59 VISUAL INSPECTIONS PERFORMED ON 3,050 PARTS WITH ZERO DEFECTS NOTED FOR FM. CLEANING WAS PERFORMED THREE TIMES DURING THE ASSEMBLY OF THIS ORDER. TOTAL PRODUCTIVE MAINTENANCE, INCLUDING ADDITIONAL CLEANING, WAS ALSO PERFORMED DURING THE ASSEMBLY OF THIS ORDER. ALL CLEANING WAS PERFORMED PER (B)(4) ¿ CLEANING PROCEDURE ¿ NEEDLE ASSEMBLY. INVESTIGATION CONCLUSION: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE. 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 ROOT CAUSE DESCRIPTION: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. RATIONALE: BASED ON THE ABOVE A CAPA IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A FOREIGN MATTER SPECK WAS FOUND IN A 19 G X 1 1/2 IN. BD NOKOR¿ FILTER NEEDLE AFTER DRAWING UP MEDICATION. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637615 19 G X 1 1/2 IN. BD NOKOR¿ FILTER NEEDLE FILTER NEEDLE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 6235636

    Patients

    Seq Age Sex Outcome Treatment
    1 Other