BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18856653 · Received March 7, 2024

    Report

    Report Number
    9617032-2024-00303
    Event Type
    Malfunction
    Date Received
    March 7, 2024
    Date of Event
    February 15, 2024
    Report Date
    March 26, 2024
    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
    SP
    Reporter Occupation
    NURSE
    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: 22-MAR-2024. H.6. INVESTIGATION SUMMARY: MATERIAL #: 368835 LOT/BATCH #: 3242438 BD RECEIVED 54 SAMPLES AND 2 PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED, AND THEY SHOW THE PRODUCT PACKAGING. ADDITIONALLY, 10 OF THE CUSTOMER SAMPLES WERE EVALUATED BY FUNCTIONAL DRAW TESTING AND THE INDICATED FAILURE MODES FOR HUB-HOLDER SEPARATION AND LEAKAGE WITH THE INCIDENT LOT WERE 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. WHILE BD WAS UNABLE TO CONFIRM THIS COMPLAINT FOR THE INDICATED FAILURE MODE HUB-HOLDER SEPARATION, BD HAS INITIATED FURTHER ROOT CAUSE INVESTIGATION RELATING TO THE ISSUE OF HUB-HOLDER SEPARATION THROUGH CORRECTIVE AND PREVENTIVE ACTIONS. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE LEAKAGE FAILURE MODE.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER, THERE WERE THREE OCCURRENCES WHERE THE TUBE HOLDER SEPARATED FROM THE HUB OF THE NEEDLE. NO PATIENT IMPACT OR INJURY REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN USING THE BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER, THERE WERE THREE OCCURRENCES WHERE THE TUBE HOLDER SEPARATED FROM THE HUB OF THE NEEDLE. NO PATIENT IMPACT OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2378789 BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 3242438 30382903688358

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown