BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 17374810 · Received July 21, 2023

    Report

    Report Number
    1024879-2023-00489
    Event Type
    Malfunction
    Date Received
    July 21, 2023
    Date of Event
    June 29, 2023
    Report Date
    July 25, 2023
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. B5. DESCRIBE EVENT OR PROBLEM: EVENT OCCURRENCE HAS BEEN UPDATED TO 2. D9: DEVICE AVAILABLE FOR EVALUATION: YES, D9: RETURNED TO MANUFACTURER ON: 2023-07-11. H.6. INVESTIGATION SUMMARY: MATERIAL #: 368607; LOT/BATCH #: 2200184. BD RECEIVED 11 SHELF PACKS OF SAMPLES AND 3 PHOTOS FOR INVESTIGATION. THE PHOTOS SHOW THE PRODUCT PACKAGING. TWENTY (20) OF THE CUSTOMER SAMPLES WERE EVALUATED BY FUNCTIONAL TESTING, EACH HAVING THEIR ECLIPSE SHIELDS ACTIVATED, AND THE INDICATED FAILURE MODE FOR DEFECTIVE LOCKING MECHANISM WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL PRODUCT SPECIFICATIONS WERE MET. 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 MODE DEFECTIVE LOCKING MECHANISM. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    H.3. 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 · 0

    IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE THAT THERE WAS A SAFETY SHIELD ISSUE WITH 2 NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAZARD, INJURY OR ERRONEOUS RESULTS? YES. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS THE SAFETY DEVICE ON TWO NEEDLES FROM A BOX OF BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE 21G X 1-1/4 DID NOT CLOSE. SM 368607_2200184 SAFETY SHIELD DID NOT CLOSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE THAT THERE WAS A SAFTEY SHIELD ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: HAZARD, INJURY OR ERRONEOUS RESULTS? YES. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS THE SAFETY DEVICE ON TWO NEEDLES FROM A BOX OF BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE 21G X 1-1/4 DID NOT CLOSE. SM 368607_2200184 SAFETY SHIELD DID NOT CLOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2147266 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) 368607 2200184 50382903686075

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown