BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER

    MDR report key: 8884728 · Received August 12, 2019

    Report

    Report Number
    1024879-2019-01410
    Event Type
    Malfunction
    Date Received
    August 12, 2019
    Date of Event
    July 8, 2019
    Report Date
    August 21, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    50382903686501
    PMA / PMN Number
    K982541
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND HUB/COLLAR SEPARATION WAS OBSERVED. HOWEVER, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER PHOTOS, THE CUSTOMER¿S INDICATED FAILURE MODE FOR HUB/COLLAR SEPARATION WITH THE INCIDENT LOT WAS OBSERVED. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, THE MOST LIKELY ROOT CAUSE WAS DETERMINED TO BE RELATED TO A MANUFACTURING ISSUE. 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. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SEPARATION OCCURRED AFTER USE WITH A BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "HAVE YOU HEARD ANYTHING ABOUT THE SAFETY DEVICE COMING OFF THE ECLIPSE BLD COLLECTION NEEDLES? WE HAVE HAD 5 SO FAR. 1 OF 3 COMPLAINTS. THIS COMPLAINT CAPTURES THE EVENT ON (B)(6) 2019.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9051796. MEDICAL DEVICE EXPIRATION DATE: 2022-02-28. DEVICE MANUFACTURE DATE: 2019-03-07. MEDICAL DEVICE LOT #: 9003928. MEDICAL DEVICE EXPIRATION DATE: 2021-12-31. DEVICE MANUFACTURE DATE: 2019-01-17. 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 SEPARATION OCCURRED AFTER USE WITH A BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "HAVE YOU HEARD ANYTHING ABOUT THE SAFETY DEVICE COMING OFF THE ECLIPSE BLD COLLECTION NEEDLES? WE HAVE HAD 5 SO FAR. 1 OF 3 COMPLAINTS. THIS COMPLAINT CAPTURES THE EVENT ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678134 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) SEE H.10 50382903686501

    Patients

    Seq Age Sex Outcome Treatment
    1 Other