BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 8203783 · Received December 28, 2018

    Report

    Report Number
    1911916-2018-00788
    Event Type
    Malfunction
    Date Received
    December 28, 2018
    Date of Event
    November 15, 2018
    Report Date
    January 22, 2019
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051978
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED. 53 INSPECTIONS PERFORMED - NO DEFECTS FOUND. NO NOTIFICATIONS WERE WRITTEN FOR THIS BATCH, NOR FOR THE ASSOCIATED ASSEMBLY BATCH. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 2ND RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF FOREIGN MATTER WITH LOT #8143717 REGARDING ITEM #305197. INVESTIGATION CONCLUSION: BASED ON NO SAMPLE, THE INVESTIGATION CONCLUDED, BD WAS NOT ABLE TO VERIFY THE INDICATED FAILURE. ROOT CAUSE DESCRIPTION: NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. 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 MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD PRECISIONGLIDE¿ NEEDLE THERE WAS AN ISSUE WITH WHITE PARTICULATE MATTER FOUND IN THE NEEDLE CAP.

    Additional Manufacturer Narrative · 1

    (B)(6). THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON 2018-11-19. MEDWATCH REPORT # MW5081473A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE BD PRECISIONGLIDE¿ NEEDLE THERE WAS AN ISSUE WITH WHITE PARTICULATE MATTER FOUND IN THE NEEDLE CAP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1044198 BD PRECISIONGLIDE¿ NEEDLE NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 8143717 30382903051978

    Patients

    Seq Age Sex Outcome Treatment
    1 Other