BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE

    MDR report key: 10186747 · Received June 23, 2020

    Report

    Report Number
    1024879-2020-00419
    Event Type
    Malfunction
    Date Received
    June 23, 2020
    Date of Event
    June 3, 2020
    Report Date
    June 29, 2020
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    50382903686075
    PMA / PMN Number
    K982541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE LABELS ON AN UNSPECIFIED NUMBER OF BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLES FROM LOTS 0003867, 9322165, AND 0010852 HAD PARTIALLY PEELED OFF AND STUCK TOGETHER BEFORE USE DURING THE KITTING PROCESS. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LABELS ON NEEDLE ARE LIFTING OFF AND ATTACHING TO OTHER LABELS, CAUSING NEEDLES TO STICK TOGETHER. THIS CAUSES KITTING OPERATION TO SHUT DOWN TO CORRECT AND RESTART OPERATION."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0003867, MEDICAL DEVICE EXPIRATION DATE: 2024-12-31, DEVICE MANUFACTURE DATE: 2020-01-03. MEDICAL DEVICE LOT #: 9322165, MEDICAL DEVICE EXPIRATION DATE: 2024-11-30, DEVICE MANUFACTURE DATE: 2019-11-18. MEDICAL DEVICE LOT #: 0010852, MEDICAL DEVICE EXPIRATION DATE: 2024-12-31, DEVICE MANUFACTURE DATE: 2020-01-10.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LABELS ON AN UNSPECIFIED NUMBER OF BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLES FROM LOTS 0003867, 9322165, AND 0010852 HAD PARTIALLY PEELED OFF AND STUCK TOGETHER BEFORE USE DURING THE KITTING PROCESS. THIS COMPLAINT WAS CREATED TO CAPTURE THE 2ND OF 2 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "LABELS ON NEEDLE ARE LIFTING OFF AND ATTACHING TO OTHER LABELS, CAUSING NEEDLES TO STICK TOGETHER. THIS CAUSES KITTING OPERATION TO SHUT DOWN TO CORRECT AND RESTART OPERATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646539 BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) 368607 SEE SECTION H.10. 50382903686075

    Patients

    Seq Age Sex Outcome Treatment
    1 Other