BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER

    MDR report key: 18271202 · Received December 5, 2023

    Report

    Report Number
    9617032-2023-01747
    Event Type
    Malfunction
    Date Received
    December 5, 2023
    Date of Event
    November 9, 2023
    Report Date
    December 7, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    30382903688358
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. D10: DEVICE AVAILABLE FOR EVALUATION: YES D10: RETURNED TO MANUFACTURER ON: 14-DEC-2023 H.6. INVESTIGATION SUMMARY: MATERIAL #: 368835 LOT/BATCH #: 3242435 BD RECEIVED 5 SAMPLES AND 2 PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR CANNULA BREAKS OFF WAS OBSERVED. THE CUSTOMER SAMPLES WERE EVALUATED BY FUNCTIONAL TESTING, EACH USED TO DRAW 6 VACUTAINER TUBES, AND THE INDICATED FAILURE MODE FOR CANNULA BREAKS OFF WITH THE INCIDENT LOT WAS NOT OBSERVED AS ALL PRODUCT SPECIFICATIONS WERE MET. ADDITIONALLY, 10 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING, EACH USED TO DRAW 6 VACUTAINER TUBES, AND THE ISSUE OF CANNULA BREAKS OFF 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 CANNULA BREAKS OFF. 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.

    Additional Manufacturer Narrative · 0

    H.3. 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 · 0

    IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER, A NEEDLE BROKE OFF FROM THE SLEEVE DURING A BLOOD DRAW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER, A NEEDLE BROKE OFF FROM THE SLEEVE DURING A BLOOD DRAW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2179007 BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 3242435 30382903688358

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown