BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 19006851 · Received March 29, 2024

    Report

    Report Number
    1024879-2024-00285
    Event Type
    Injury
    Date Received
    March 29, 2024
    Date of Event
    March 5, 2024
    Report Date
    May 8, 2024
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    00382903686513
    PMA / PMN Number
    K982541
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E.1 (B)(6). H.3. 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 WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. D.9:DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 2024-APRIL ¿ 10TH. H.6 INVESTIGATION SUMMARY: MATERIAL #: 368651. LOT/BATCH #: 3223395. BD RECEIVED (B)(4) AND 1 PHOTO FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR DEFECTIVE LOCKING MECHANISM WAS OBSERVED. ADDITIONALLY, (B)(4) OF THE CUSTOMER SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND FUNCTIONAL TESTING AND THE INDICATED FAILURE MODE FOR DEFECTIVE LOCKING MECHANISM WITH THE INCIDENT LOT WAS NOT OBSERVED. 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 HAS BEEN 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER, THE SAFETY SHIELD FELL OFF OF ONE DEVICE RESULTING IN A NEEDLESTICK INJURY. PER CUSTOMER, THERE WAS NO POST EXPOSURE TESTING OR MEDICAL INTERVENTION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER, THE SAFETY SHIELD FELL OFF OF ONE DEVICE RESULTING IN A NEEDLESTICK INJURY. PER CUSTOMER, THERE WAS NO POST EXPOSURE TESTING OR MEDICAL INTERVENTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2586865 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) 3223395 00382903686513

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other