BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 16389675 · Received February 16, 2023

    Report

    Report Number
    1710034-2023-00115
    Event Type
    Malfunction
    Date Received
    February 16, 2023
    Date of Event
    February 13, 2023
    Report Date
    April 4, 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
    JA
    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. THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH 510(K) NUMBER IS AS FOLLOWS: COMMON DEVICE NAME: INTRAVASCULAR ADMINISTRATION SET. MEDICAL DEVICE TYPE: FPA. 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 #: 367324. LOT/BATCH #: 2131350. BD HAD NOT RECEIVED SAMPLES, BUT FOUR PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE TUBING APPEARED TO BE DAMAGED NEAR THE LUER HUB. DUE TO THE DAMAGE THAT WAS OBSERVED ON THE TUBING, THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE OF LEAKAGE. 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. 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. 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. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THERE WAS BLOOD LEAKAGE OCCURRING DURING THE USE OF WINGET PBBCS. THERE WAS NO MEDICAL INTERVENTIONS REQUIRED."

    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. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THERE WAS BLOOD LEAKAGE OCCURRING DURING THE USE OF WINGET PBBCS. THERE WAS NO MEDICAL INTERVENTIONS REQUIRED.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389881 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 367324 2131350 50382903673242

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown