BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18275210 · Received December 6, 2023

    Report

    Report Number
    9617032-2023-01755
    Event Type
    Malfunction
    Date Received
    December 6, 2023
    Date of Event
    November 8, 2023
    Report Date
    December 8, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    30382903688358
    PMA / PMN Number
    K030573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: MATERIAL #: 368835 LOT/BATCH #: 0133833. BD HAD NOT RECEIVED SAMPLES, BUT 2 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED, HOWEVER THEY ARE NOT PHOTOS OF THE ACTUAL DEFECTIVE DEVICE. ADDITIONALLY, 50 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED RELATING TO MISSING IV SHIELD 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 MISSING IV SHIELD. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    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. H3 OTHER TEXT : NA

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UPON OPENING THE PACKAGING OF THE BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE W/ HOLDER, IT WAS FOUND THAT THE I.V SHIELD WAS MISSING. THIS EVENT OCCURRED 1 TIME AND NO REPORT OF ADVERSE OR INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT UPON OPENING THE PACKAGING OF THE BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE W/ HOLDER, IT WAS FOUND THAT THE I.V SHIELD WAS MISSING. THIS EVENT OCCURRED 1 TIME AND NO REPORT OF ADVERSE OR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2072240 BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE WITH INTEGRATED HOLDER BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 0133833 30382903688358

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown