BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 10936646 · Received December 2, 2020

    Report

    Report Number
    1920898-2020-01660
    Event Type
    Malfunction
    Date Received
    December 2, 2020
    Date of Event
    November 12, 2020
    Report Date
    February 10, 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
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED SAMPLES AND PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR DAMAGED TUBING WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, THE CUSTOMER SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR DAMAGED TUBING WITH THE INCIDENT LOT WAS OBSERVED. THE ROOT CAUSE WAS LINKED TO A MANUFACTURING OPERATOR ERROR. 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.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET EXPERIENCED FAILURE OF PRODUCT TO CONTAIN BLOOD/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRANSLATED TO ENGLISH. THE CUSTOMER STATED THERE WAS A "DAMAGED (CUT) TUBING OF THE WINGSET."

    Description of Event or Problem · 0

    IT WAS REPORTED THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET EXPERIENCED FAILURE OF PRODUCT TO CONTAIN BLOOD/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRANSLATED TO ENGLISH. THE CUSTOMER STATED THERE WAS A "DAMAGED (CUT) TUBING OF THE WINGSET."

    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. 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 THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET EXPERIENCED FAILURE OF PRODUCT TO CONTAIN BLOOD/MEDICATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRANSLATED TO ENGLISH. THE CUSTOMER STATED THERE WAS A, "DAMAGED (CUT) TUBING OF THE WINGSET."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1396687 BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 367324 0073799 50382903673242

    Patients

    Seq Age Sex Outcome Treatment
    1