BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 10869036 · Received November 19, 2020

    Report

    Report Number
    1920898-2020-01591
    Event Type
    Malfunction
    Date Received
    November 19, 2020
    Date of Event
    October 29, 2020
    Report Date
    February 19, 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
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: D.3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. ¿ SANDY, UT / 84070. G.2 MANUFACTURING LOCATION: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. ¿ SANDY, UT / 84070.

    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: 1/12/2021. H.6. INVESTIGATION: BD RECEIVED SAMPLES FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE INDICATED FAILURE MODE FOR DAMAGED WITH THE INCIDENT LOT WAS OBSERVED. THE MOST LIKELY ROOT CAUSE OF THE CUSTOMER'S INDICATED FAILURE MODE FOR DAMAGED WAS DETERMINED TO BE RELATED TO MANUFACTURING. 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD LEAKED OUT OF TUBING. THERE WAS NO REPORTED PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE TUBING ON THE BUTTERFLY WAS MALFORMED WHICH RESULTED IN BLOOD SPILLING OUTSIDE THE TUBE. CARDINAL HEALTH CANADA HAS RECEIVED THE FOLLOWING PRODUCT VERBATIM: THE TUBING ON THE BUTTERFLY WAS MALFORMED AND THE PATIENTS BLOOD POURED OUT OF THE OPENING INSTEAD OF BEING DRAWN INTO THE TUBE. THIS IS A SAFETY ISSUE FOR STAFF AND BLOOD WAS SPILLING EVERYWHERE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD LEAKED OUT OF TUBING. THERE WAS NO REPORTED PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE TUBING ON THE BUTTERFLY WAS MALFORMED WHICH RESULTED IN BLOOD SPILLING OUTSIDE THE TUBE. CARDINAL HEALTH CANADA HAS RECEIVED THE FOLLOWING PRODUCT VERBATIM: THE TUBING ON THE BUTTERFLY WAS MALFORMED AND THE PATIENTS BLOOD POURED OUT OF THE OPENING INSTEAD OF BEING DRAWN INTO THE TUBE. THIS IS A SAFETY ISSUE FOR STAFF AND BLOOD WAS SPILLING EVERYWHERE.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL DEVICE TYPE IS AS FOLLOWS: MEDICAL DEVICE TYPE: FPA; COMMON DEVICE NAME: INTRAVASCULAR ADMINISTRATION SET. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD LEAKED OUT OF TUBING. THERE WAS NO REPORTED PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE TUBING ON THE BUTTERFLY WAS MALFORMED, WHICH RESULTED IN BLOOD SPILLING OUTSIDE THE TUBE. CARDINAL HEALTH CANADA HAS RECEIVED THE FOLLOWING PRODUCT VERBATIM: THE TUBING ON THE BUTTERFLY WAS MALFORMED, AND THE PATIENTS BLOOD POURED OUT OF THE OPENING INSTEAD OF BEING DRAWN INTO THE TUBE. THIS IS A SAFETY ISSUE FOR STAFF, AND BLOOD WAS SPILLING EVERYWHERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1333475 BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 367324 0073800 50382903673242

    Patients

    Seq Age Sex Outcome Treatment
    1