BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 17139787 · Received June 15, 2023

    Report

    Report Number
    1024879-2023-00380
    Event Type
    Malfunction
    Date Received
    June 15, 2023
    Date of Event
    May 4, 2023
    Report Date
    June 26, 2023
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903673440
    PMA / PMN Number
    K030573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: MATERIAL #: 367344 LOT/BATCH #: 3061934 BD HAD NOT RECEIVED SAMPLES, BUT 1 PHOTO WAS PROVIDED FOR INVESTIGATION. THE PHOTO WAS REVIEWED AND IT SHOWS THE PRODUCT PACKAGING. ADDITIONALLY, 30 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL DRAW TESTING AND RETRACTION TESTING AND NO ISSUES WERE OBSERVED RELATING TO LEAKAGE / SPLATTER 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 LEAKAGE. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET REPORTED THAT GREEN & BLUE BUTTERFLY PUSH BUTTON NEEDLES SPRAY TINY BLOOD DROPLETS WHEN THE PUSH BUTTON SAFETY IS ACTIVATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "IT WAS REPORTED BY THE CUSTOMER THAT 367344_3061934 LEAKING."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET REPORTED THAT GREEN & BLUE BUTTERFLY PUSH BUTTON NEEDLES SPRAY TINY BLOOD DROPLETS WHEN THE PUSH BUTTON SAFETY IS ACTIVATED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "IT WAS REPORTED BY THE CUSTOMER THAT (B)(6)LEAKING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2103042 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET JKA BECTON, DICKINSON & CO., (BD) 367344 3061934 50382903673440

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown