BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 15939609 · Received December 8, 2022

    Report

    Report Number
    1710034-2022-00765
    Event Type
    Malfunction
    Date Received
    December 8, 2022
    Date of Event
    November 15, 2022
    Report Date
    January 23, 2023
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    JKA
    UDI-DI
    50382903673242
    PMA / PMN Number
    K030573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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: BD RECEIVED 62 SEALED REPRESENTATIVE SAMPLES FROM LOT #2153246 FOR INVESTIGATION. THE CUSTOMER SAMPLES VISUALLY INSPECTED AND FUNCTIONALLY TESTED AND NO ISSUES RELATING TO LEAKAGE OR AIR BUBBLES WERE 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 IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE OF LEAKING. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. H3 OTHER TEXT : SEE H.10

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THERE WAS BLOOD LEAKAGE OR OTHER SAMPLE LEAKAGE FROM THE DEVICE OTHER THAN THE INSERTION SITE OR NEEDLE TIP AND AIR BUBBLES IN THE GEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE IS LEAKING AROUND THE HUB AND AIR IS BACKED UP IN THE TUBING.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THERE WAS BLOOD LEAKAGE OR OTHER SAMPLE LEAKAGE FROM THE DEVICE OTHER THAN THE INSERTION SITE OR NEEDLE TIP AND AIR BUBBLES IN THE GEL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE IS LEAKING AROUND THE HUB AND AIR IS BACKED UP IN THE TUBING

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2586558 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 367324 2153246 50382903673242

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown