BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 15432404 · Received September 15, 2022

    Report

    Report Number
    1024879-2022-00530
    Event Type
    Malfunction
    Date Received
    September 15, 2022
    Date of Event
    August 30, 2022
    Report Date
    October 25, 2022
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    50382903686075
    PMA / PMN Number
    K982541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1223473, MEDICAL DEVICE EXPIRATION DATE: 2026-07-31, DEVICE MANUFACTURE DATE: 2021-08-11. MEDICAL DEVICE LOT #: 1063107, MEDICAL DEVICE EXPIRATION DATE: 2026-02-28, DEVICE MANUFACTURE DATE: 2021-03-04. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. D9: RETURNED TO MANUFACTURER ON: 2022-10-13. H.6. INVESTIGATION SUMMARY: BD RECEIVED 4 SAMPLES AND 1 PHOTO FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODES FOR NEEDLE BEVEL NOT SMOOTH / FOREIGN MATTER WITH THE INCIDENT LOT WAS NOT OBSERVED AS THE PHOTO IS NOT CLEAR ENOUGH TO ADEQUATELY INSPECT THE NEEDLE BEVEL. THE CUSTOMER SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODES FOR NEEDLE BEVEL NOT SMOOTH / FOREIGN MATTER WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL PRODUCT SPECIFICATIONS WERE MET. ADDITIONALLY, 60 RETENTION SAMPLES (30 FROM EACH REPORTED LOT) FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED RELATING TO NEEDLE BEVEL NOT SMOOTH / FOREIGN MATTER AS ALL SAMPLES MET SPECIFICATIONS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODES NEEDLE BEVEL NOT SMOOTH / FOREIGN MATTER. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE THERE WAS FOREIGN MATTER ON DEVICE NEEDLE OR ANY FLUID PATH COMPONENT. THIS EVENT OCCURRED 92 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE NEEDLE HAS A GEL-LIKE OBJECT, BEFORE USE."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE THERE WAS FOREIGN MATTER ON DEVICE NEEDLE OR ANY FLUID PATH COMPONENT. THIS EVENT OCCURRED 92 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE NEEDLE HAS A GEL-LIKE OBJECT, BEFORE USE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1467015 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) 368607 SEE H.10 50382903686075

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown