BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 18613155 · Received January 31, 2024

    Report

    Report Number
    1024879-2024-00068
    Event Type
    Malfunction
    Date Received
    January 31, 2024
    Date of Event
    January 4, 2024
    Report Date
    May 18, 2024
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903673426
    PMA / PMN Number
    K030573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY MATERIAL #: 367342 LOT/BATCH #: 3262805 BD HAD NOT RECEIVED SAMPLES, BUT TWO (2) PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR BREAKING OFF DURING USE WAS OBSERVED. ADDITIONALLY, THIRTY (30) RETENTION SAMPLES FROM BD INVENTORY WERE SUBJECTED TO A DRAW TEST TO ASSESS FUNCTIONALITY OF THE DEVICE AND THE ISSUE OF DAMAGE OR BREAKAGE DURING USE WAS NOT OBSERVED. ALSO, THE 30 RETAIN SAMPLES WERE SUBJECTED TO RETRACTION LOCKOUT TESTING. ALL SAMPLES PASSED TESTING AS THEY WERE ABLE TO BE ACTIVATED PROPERLY WITH NO EVIDENCE OF BREAKAGE. 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 OF BREAKING OFF DURING USE. 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.

    Additional Manufacturer Narrative · 0

    G.5 PMA / 510(K)# K030573, K220212 D2: COMMON DEVICE NAME: BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET 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 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THAT WHEN ENGAGING THE SAFETY DEVICE AFTER COLLECTION, DEVICE BEGAN TO SEPARATE NEAR THE HUB AND THE NEEDLE SHOT OUT ONTO THE FLOOR. UPON EXAMINATION IT WAS NOTED THEY CAN SEE THE NEEDLE INSIDE THE SHAFT AND ALSO NOTED THAT A PIECE OF THE HARD PLASTIC ON THE HUB HAD BROKEN OFF.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THAT WHEN ENGAGING THE SAFETY DEVICE AFTER COLLECTION, DEVICE BEGAN TO SEPARATE NEAR THE HUB AND THE NEEDLE SHOT OUT ONTO THE FLOOR. UPON EXAMINATION IT WAS NOTED THEY CAN SEE THE NEEDLE INSIDE THE SHAFT AND ALSO NOTED THAT A PIECE OF THE HARD PLASTIC ON THE HUB HAD BROKEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    392124 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET SEE H.10 JKA BECTON, DICKINSON & CO., (BD) 3262805 50382903673426

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown