BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    27 G X 1/2 IN. BD PRECISIONGLIDE¿ NEEDLE

    MDR report key: 6959112 · Received October 18, 2017

    Report

    Report Number
    1911916-2017-00279
    Event Type
    Malfunction
    Date Received
    October 18, 2017
    Date of Event
    September 26, 2017
    Report Date
    December 5, 2017
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    30382903051091
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. THE INVESTIGATION CONCLUDED: UNCONFIRMED: 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 BASED ON THE ABOVE A CAPA IS NOT REQUIRED AT THIS TIME. DHR WAS DONE WITH NO DEFECTS NOTED. INVESTIGATION CONCLUSION: QN REVIEW: ONE NOTIFICATION WAS WRITTEN FOR HUB DAMAGE FOR BATCH 5211675. ALL AFFECTED PRODUCT WAS SCRAPPED. ONE NOTIFICATION WAS WRITTEN FOR LOW LUBE SOLIDS FOR BATCH 6299703. THE AFFECTED PRODUCT WAS ACCEPTED ON DEVIATION. DHR REVIEW: BATCH 5239642 - ASSEMBLY BATCH 5149541 HAD 60 VISUAL INSPECTIONS PERFORMED ON 3,150 PARTS WITH ZERO DEFECTS NOTED. ASSEMBLY BATCH 5211675 HAD 55 VISUAL INSPECTIONS PERFORMED ON 2,900 PARTS WITH ZERO DEFECTS NOTED. BATCH 6339776 - ASSEMBLY BATCH 6299703 HAD 35 VISUAL INSPECTIONS PERFORMED ON 1,900 PARTS WITH ZERO DEFECTS NOTED. INVESTIGATION RESULTS: UNABLE TO COMPLETE WITHOUT SAMPLES OR PHOTOS. POSSIBLE ROOT CAUSE: UNABLE TO COMPLETE. INVESTIGATION RESULTS: UNABLE TO COMPLETE WITHOUT SAMPLES OR PHOTOS. ROOT CAUSE DESCRIPTION. POSSIBLE ROOT CAUSE: UNABLE TO COMPLETE.

    Additional Manufacturer Narrative · 1

    THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A SAMPLE IS NOT AVAILABLE FOR EVALUATION. HOWEVER, A NO SAMPLE INVESTIGATION AND DEVICE HISTORY RECORD REVIEW WILL BE COMPLETED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 27 G X 1/2 IN. BD PRECISIONGLIDE¿ NEEDLE DETACHED DURING USE RESULTING IN LOSS OF MEDICATION. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739998 27 G X 1/2 IN. BD PRECISIONGLIDE¿ NEEDLE HYPODERMIC NEEDLE FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL SEE H.10. 30382903051091

    Patients

    Seq Age Sex Outcome Treatment
    1 Other