BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 15705563 · Received October 31, 2022

    Report

    Report Number
    1024879-2022-00634
    Event Type
    Malfunction
    Date Received
    October 31, 2022
    Date of Event
    October 18, 2022
    Report Date
    November 3, 2022
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    50382903686501
    PMA / PMN Number
    K982541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 2222044, MEDICAL DEVICE EXPIRATION DATE: 2025-07-31, DEVICE MANUFACTURE DATE: 2022-08-31. MEDICAL DEVICE LOT #: 2041702, MEDICAL DEVICE EXPIRATION DATE: 2025-01-31, DEVICE MANUFACTURE DATE: 2022-03-03.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES D9: RETURNED TO MANUFACTURER ON: 2022-10-27. H.6. INVESTIGATION SUMMARY: BD RECEIVED 9 SAMPLES (7 FROM LOT# 2222044 AND 2 FROM LOT# 2041702) FOR INVESTIGATION. THE 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER CUSTOMER STATES THAT THE SAFETY SHIELD FELL OFF THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "IT WAS REPORTED BY THE CUSTOMER THAT THE SAFETY SHIELD FELL OFF THE NEEDLE."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER CUSTOMER STATES THAT THE SAFETY SHIELD FELL OFF THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "IT WAS REPORTED BY THE CUSTOMER THAT THE SAFETY SHIELD FELL OFF THE NEEDLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639407 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) 368650 2041702 50382903686501

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown