BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER

    MDR report key: 12575582 · Received October 5, 2021

    Report

    Report Number
    1024879-2021-00686
    Event Type
    Malfunction
    Date Received
    October 5, 2021
    Date of Event
    September 3, 2021
    Report Date
    October 8, 2021
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    50382903686501
    PMA / PMN Number
    K982541
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY. BD HAD NOT RECEIVED SAMPLES, BUT ONE PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND THE INDICATED FAILURE MODE FOR DEFECTIVE LOCKING MECHANISM WAS NOT OBSERVED. THE PHOTO ONLY SHOWS 2 EMPTY BLISTER PACKAGES WITHOUT ANY SAMPLES IN THEM, THEREBY NOT CONFIRMING THE REPORTED DEFECT. ADDITIONALLY, 20 RETENTION SAMPLES FROM BD INVENTORY FROM EACH LOT WERE EVALUATED BY VISUAL FUNCTIONAL TESTING FOR PROPER ACTIVATION 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. WHILE BD WAS UNABLE TO CONFIRM THIS COMPLAINT FOR THE INDICATED FAILURE MODE DEFECTIVE LOCKING MECHANISM, BD HAS INITIATED FURTHER ROOT CAUSE INVESTIGATION RELATING TO THE ISSUE OF DEFECTIVE LOCKING MECHANISM THROUGH CORRECTIVE AND PREVENTIVE ACTIONS. CAPA 1465371 HAS BEEN INITIATED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER, THE DEVICE EXPERIENCED SAFETY SHIELD FAILURE ¿ E.G. SHIELD BREAKS OFF FROM NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT IS REPORTED SAFETY SHIELD BROKE OFF. BROKEN DEVICES - THEY JUST SNAPPED OFF. CUSTOMER VERIFIED THAT THEY WERE TRYING TO ACTIVATE THE NORMAL WAY (WITH THE THUMB) AND THEY WEREN¿T AGGRESSIVE.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1091965, MEDICAL DEVICE EXPIRATION DATE: 2024-03-31, DEVICE MANUFACTURE DATE: 2021-04-01, MEDICAL DEVICE LOT #: 1132894, MEDICAL DEVICE EXPIRATION DATE: 2024-04-30, DEVICE MANUFACTURE DATE: 2021-05-12. 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 · 1

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER, THE DEVICE EXPERIENCED SAFETY SHIELD FAILURE ¿ E.G. SHIELD BREAKS OFF FROM NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT IS REPORTED SAFETY SHIELD BROKE OFF. BROKEN DEVICES - THEY JUST SNAPPED OFF. CUSTOMER VERIFIED THAT THEY WERE TRYING TO ACTIVATE THE NORMAL WAY (WITH THE THUMB) AND THEY WEREN'T AGGRESSIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1475520 BD VACUTAINER ECLIPSE BLOOD COLLECTION NEEDLE WITH PRE-ATTACHED HOLDER HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON, DICKINSON & CO., (BD) 368650 SEE H.10. 50382903686501

    Patients

    Seq Age Sex Outcome Treatment
    1