BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 9193724 · Received October 15, 2019

    Report

    Report Number
    1024879-2019-01812
    Event Type
    Malfunction
    Date Received
    October 15, 2019
    Date of Event
    October 1, 2019
    Report Date
    October 21, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    50382903686075
    PMA / PMN Number
    K982541
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 SAFETY SHIELD SEPARATION WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, EVALUATION & TESTING OF THE CUSTOMER SAMPLES WAS PERFORMED AND SAFETY SHIELD SEPARATION 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLES EXPERIENCED SAFETY SHIELD FAILURE PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 368607, BATCH NO. 9182744. PER EMAIL: WE HAVE HAD 4 NEEDLES LAST WEEK HAVE THE FOLLOWING ISSUES, WHEN LAB ASSISTANT REMOVES THE CAP THE SAFETY BREAKS OFF. I HAVE REMOVED THE LOT FROM OUR COLLECTION OF NEEDLES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 AN UNSPECIFIED NUMBER OF BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLES EXPERIENCED SAFETY SHIELD FAILURE PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 368607. BATCH NO. 9182744. PER EMAIL: WE HAVE HAD 4 NEEDLES LAST WEEK HAVE THE FOLLOWING ISSUES, WHEN LAB ASSISTANT REMOVES THE CAP THE SAFETY BREAKS OFF. I HAVE REMOVED THE LOT FROM OUR COLLECTION OF NEEDLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    983801 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) 9182744 50382903686075

    Patients

    Seq Age Sex Outcome Treatment
    1 Other