BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 8664083 · Received June 3, 2019

    Report

    Report Number
    1024879-2019-00952
    Event Type
    Injury
    Date Received
    June 3, 2019
    Date of Event
    May 13, 2019
    Report Date
    June 21, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    50382903686082
    PMA / PMN Number
    K982541
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR SAFETY SHIELD SEPARATION WITH THE INCIDENT LOT WAS NOT 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 SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR SAFETY SHIELD SEPARATION WITH THE INCIDENT LOT WAS NOT OBSERVED. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE EXPERIENCED A SAFETY SHIELD FAILURE, CAUSING A SERIOUS INJURY IN THE FORM OF A DIRTY NEEDLE STICK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 368608, BATCH NO. 8222875. BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE ¿ 22 GAUGE. EVENT DATE: (B)(6) 2019. REF # 368608. LOT # 8222875. DESCRIPTION: THE NEEDLE SAFETY GUARD DID NOT COVER THE NEEDLE AFTER USE ¿ NEEDLE STICK TO EMPLOYEE. SEVERAL BOXES OF THIS LOT ARE AVAILABLE FOR RETURN AND REVIEW.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: 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 THAT THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE EXPERIENCED A SAFETY SHIELD FAILURE, CAUSING A SERIOUS INJURY IN THE FORM OF A DIRTY NEEDLE STICK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 368608, BATCH NO. 8222875. BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE ¿ 22 GAUGE. EVENT DATE: 5/13/2019, REF # 368608, LOT # 8222875. DESCRIPTION: THE NEEDLE SAFETY GUARD DID NOT COVER THE NEEDLE AFTER USE ¿ NEEDLE STICK TO EMPLOYEE. SEVERAL BOXES OF THIS LOT ARE AVAILABLE FOR RETURN AND REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455393 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) 8222875 50382903686082

    Patients

    Seq Age Sex Outcome Treatment
    1 Other