BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17444012 · Received August 2, 2023

    Report

    Report Number
    1024879-2023-00526
    Event Type
    Malfunction
    Date Received
    August 2, 2023
    Date of Event
    June 14, 2023
    Report Date
    November 1, 2023
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    50382903686501
    PMA / PMN Number
    K982541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4. MEDICAL DEVICE LOT #: UNKNOWN. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. 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

    H.6 INVESTIGATION SUMMARY: MATERIAL #: 368650. LOT/BATCH #: 3073407. BD HAD NOT RECEIVED SAMPLES, BUT 3 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR DEFECTIVE LOCKING MECHANISM WAS OBSERVED. ADDITIONALLY, 20 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING, EACH HAVING THEIR ECLIPSE SHIELD ACTIVATED, AND THE ISSUE OF DEFECTIVE LOCKING MECHANISM 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER THAT THERE WAS SAFTEY SHIELD FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER PROBLEM: CUSTOMER REPORTS THAT SAFETY DEVICE BREAKS OFF WHILE USING CAT 368650. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: PER CUSTOMER, PINK SAFETY DEVICE IS BREAKING OFF FROM BASE WHEN COVERING THE SAFETY NEEDLE. THIS CAUSES THE SAFETY SHIELD TO SLIDE FURTHER ALONG THE NEEDLE AND CREATING A POTENTIAL NEEDLE STICK INJURY. CUSTOMER REPORTS THAT SAFETY DEVICE BREAKS OFF WHILE USING CAT 368650.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER THAT THERE WAS SAFTEY SHIELD FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER PROBLEM: CUSTOMER REPORTS THAT SAFETY DEVICE BREAKS OFF WHILE USING CAT 368650. -STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: PER CUSTOMER, PINK SAFETY DEVICE IS BREAKING OFF FROM BASE WHEN COVERING THE SAFETY NEEDLE. THIS CAUSES THE SAFETY SHIELD TO SLIDE FURTHER ALONG THE NEEDLE AND CREATING A POTENTIAL NEEDLE STICK INJURY. CUSTOMER REPORTS THAT SAFETY DEVICE BREAKS OFF WHILE USING CAT 368650.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1261175 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) UNKNOWN 50382903686501

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown