BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 10782670 · Received November 3, 2020

    Report

    Report Number
    1920898-2020-01526
    Event Type
    Malfunction
    Date Received
    November 3, 2020
    Date of Event
    October 14, 2020
    Report Date
    January 7, 2021
    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
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO CORRECTION INFORMATION: D.3. MANUFACTURER NAME: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. G.1.MANUFACTURER LOCATION: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. G.7. TYPE OR REPORT: FOLLOW UP #1

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 11/18/2020. H.6. INVESTIGATION: BD RECEIVED SAMPLES FROM THE CUSTOMER FOR INVESTIGATION. ALL SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR PREACTIVATION WITH THE INCIDENT LOT WAS 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 NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. BD HAS INITIATED FURTHER ROOT CAUSE INVESTIGATION RELATING TO THE ISSUE OF PREACTIVATION THROUGH CAPA#1762367.

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET IT WAS DIFFICULT TO ACTIVATE SAFETY FEATURE. THIS EVENT OCCURRED 36 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED "THE WINGSET IS SNAPPING APART. THE CUSTOMER PERFORMED A DESTRUCTIVE TEST ON BD PRODUCT TO CONFIRM STRENGTH OF THE LEVER ARM THIS TEST PROTOCOL HAS BEEN SHARED WITH THE BD TEAM IN SAN ANTONIO."

    Description of Event or Problem · 0

    IT WAS REPORTED WITH THE USE OF THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET IT WAS DIFFICULT TO ACTIVATE SAFETY FEATURE. THIS EVENT OCCURRED 36 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED "THE WINGSET IS SNAPPING APART. THE CUSTOMER PERFORMED A DESTRUCTIVE TEST ON BD PRODUCT TO CONFIRM STRENGTH OF THE LEVER ARM ¿ THIS TEST PROTOCOL HAS BEEN SHARED WITH THE BD TEAM IN (B)(6)."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: COMMON DEVICE NAME: INTRAVASCULAR ADMINISTRATION SET, MEDICAL DEVICE TYPE: FPA. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0073799, DEVICE MANUFACTURE DATE: 2020-03-31, MEDICAL DEVICE LOT #: 0078102, DEVICE MANUFACTURE DATE: 2020-04-16. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED WITH THE USE OF THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET IT WAS DIFFICULT TO ACTIVATE SAFETY FEATURE. THIS EVENT OCCURRED 36 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER STATED "THE WINGSET IS SNAPPING APART. THE CUSTOMER PERFORMED A DESTRUCTIVE TEST ON BD PRODUCT TO CONFIRM STRENGTH OF THE LEVER ARM ¿ THIS TEST PROTOCOL HAS BEEN SHARED WITH THE BD TEAM IN (B)(6)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1241242 BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 367324 0078102 50382903673242

    Patients

    Seq Age Sex Outcome Treatment
    1