BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE W/ HOLDER

    MDR report key: 15351219 · Received September 2, 2022

    Report

    Report Number
    9617032-2022-00820
    Event Type
    Malfunction
    Date Received
    September 2, 2022
    Date of Event
    August 18, 2022
    Report Date
    September 27, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. D9: RETURNED TO MANUFACTURER ON: 2022-09-27. "MATERIAL #: 368836. LOT/BATCH #: 2091499. BD RECEIVED 1 SAMPLE FOR INVESTIGATION. THE SAMPLE WAS EVALUATED BY FUNCTIONAL TESTING, USED TO DRAW 6 BD VACUTAINER TUBES WITH WATER, AND THE INDICATED FAILURE MODE FOR DEVICE SEPARATES / LEAKAGE WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING, EACH USED TO DRAW 5 BD VACUTAINER TUBES WITH WATER, AND NO ISSUES WERE OBSERVED RELATING TO DEVICE SEPARATES / LEAKAGE AS ALL SAMPLES MET SPECIFICATIONS. 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 DEVICE SEPARATES / LEAKAGE. 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."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE W/ HOLDER THERE WAS NEEDLE AND HOLDER SEPARATION AND BLOOD LEAKAGE OR OTHER SAMPLE LEAKAGE FROM THE DEVICE OTHER THAN THE INSERTION SITE OR NEEDLE TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "DURING BLOOD COLLECTION, THE NEEDLE AND THE VACUTAINER BROKE APART ON THE VACUTAINER SYSTEM. THE BLOOD COLLECTION COULD THEREFORE NOT BE PERFORMED AS THE TUBES COULD NOT BE CONNECTED TO THE NEEDLE. INJURY DUE TO BROKEN SYSTEM, CONTAMINATION WITH FOREIGN BLOOD. ADDITIONAL INFORMATION RECEIVED: 08/23/2022 CUSTOMER CONFIRMED THAT THERE WAS NO INJURY AND NO BLOOD EXPOSURE

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE W/ HOLDER THERE WAS NEEDLE AND HOLDER SEPARATION AND BLOOD LEAKAGE OR OTHER SAMPLE LEAKAGE FROM THE DEVICE OTHER THAN THE INSERTION SITE OR NEEDLE TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "DURING BLOOD COLLECTION, THE NEEDLE AND THE VACUTAINER BROKE APART ON THE VACUTAINER SYSTEM. THE BLOOD COLLECTION COULD THEREFORE NOT BE PERFORMED AS THE TUBES COULD NOT BE CONNECTED TO THE NEEDLE. INJURY DUE TO BROKEN SYSTEM, CONTAMINATION WITH FOREIGN BLOOD. ADDITIONAL INFORMATION RECEIVED: 08/23/2022 CUSTOMER CONFIRMED THAT THERE WAS NO INJURY AND NO BLOOD EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382829 BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE W/ HOLDER BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 2091499

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown