BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 8971685 · Received September 6, 2019

    Report

    Report Number
    1024879-2019-01590
    Event Type
    Malfunction
    Date Received
    September 6, 2019
    Date of Event
    August 16, 2019
    Report Date
    October 7, 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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY:BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR LEAKAGE WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR TESTING AND UPON COMPLETION, THE ISSUE RELATING TO LEAKAGE 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 LEAKAGE OCCURRED DURING USE WITH A BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THERE A KIND PERSON (BD SALES REPRESENTATIVE FROM ARIZONA) HEAR ABOUT THE PROBLEMS THAT I HAD WITH THE SECURITY NEEDLE LOT. #9080851 WITH EXPIRATION DATE 2024-03-31, AND BRING ME YOUR EMAIL. THE RUBBER THAT COVER THE NEEDLE THAT IS INSIDE OF THE VACUTAINER BENDS, FREEING THE NEEDLE CAUSING BLOODSHED IN THE VACUTAINER AND THE PATIENT'S SKIN. I HAVE 36 BRANCHES AND 6 OF THEM HAVE THIS PROBLEM. I ASKED ALL MY BRANCHES TO SEND ME ALL THE BOXES WITH THAT LOT AND I HAVE THEM IN QUARANTINE UNTIL THE DISTRIBUTOR TELLS ME WHAT THEY ARE GOING TO DO."

    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 LEAKAGE OCCURRED DURING USE WITH A BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THERE A KIND PERSON (BD SALES REPRESENTATIVE FROM (B)(4)) HEAR ABOUT THE PROBLEMS THAT I HAD WITH THE SECURITY NEEDLE LOT 9080851 WITH EXPIRATION DATE 2024-03-31 AND BRING ME YOUR EMAIL. THE RUBBER THAT COVER THE NEEDLE THAT IS INSIDE OF THE VACUTAINER BENDS FREEING THE NEEDLE CAUSING BLOODSHED IN THE VACUTAINER AND THE PATIENT'S SKIN. I HAVE 36 BRANCHES AND 6 OF THEM HAVE THIS PROBLEM. I ASKED ALL MY BRANCHES TO SEND ME ALL THE BOXES WITH THAT LOT AND I HAVE THEM IN QUARANTINE UNTIL THE DISTRIBUTOR TELLS ME WHAT THEY ARE GOING TO DO."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764669 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) 9080851 50382903686075

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other