BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 11777900 · Received May 5, 2021

    Report

    Report Number
    1024879-2021-00293
    Event Type
    Malfunction
    Date Received
    May 5, 2021
    Date of Event
    April 8, 2021
    Report Date
    June 21, 2021
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    JKA
    UDI-DI
    50382903673440
    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO CORRECTIONS: D.3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. G.9. MANUFACTURING LOCATION: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: THE REPORTED DEFECT HAS BEEN CONFIRMED BASED ON THE CUSTOMER PHOTOS AND RETURNED UNIT INSPECTION. RETURNED WAS ONE 21GA X 3/4 IN PBBCS DEVICES IN AN OPENED PACKAGE. THE ROOT CAUSE IS LINKED TO THE MANUFACTURING. CAPA#1762367 WAS INITIATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET EXPERIENCED RETRACTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE CUSTOMER REPORTED AS FOLLOWS: "DURING PUNCTURE, THE NEEDLE WAS RETRACTED. THIS INCIDENT REQUIRED BLOOD RE-COLLECTION." ADDITIONAL INFORMATION RECEIVED: BDJ RECEIVED AN ACTUAL USED SAMPLE AND THE NEEDLE WAS HALF RETRACTED. THE TIP OF NEEDLE WAS EXISTED OUT OF BARREL. THE PUSHING BUTTON WASN'T MOVED AND LOOKED BROKEN."

    Description of Event or Problem · 0

    IT WAS REPORTED THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET EXPERIENCED RETRACTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE CUSTOMER REPORTED AS FOLLOWS: "DURING PUNCTURE, THE NEEDLE WAS RETRACTED. THIS INCIDENT REQUIRED BLOOD RE-COLLECTION." ADDITIONAL INFORMATION RECEIVED: BDJ RECEIVED AN ACTUAL USED SAMPLE AND THE NEEDLE WAS HALF RETRACTED. THE TIP OF NEEDLE WAS EXISTED OUT OF BARREL. THE PUSHING BUTTON WASN'T MOVED AND LOOKED BROKEN."

    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 DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET EXPERIENCED RETRACTION ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE CUSTOMER REPORTED AS FOLLOWS: "DURING PUNCTURE, THE NEEDLE WAS RETRACTED. THIS INCIDENT REQUIRED BLOOD RE-COLLECTION." ADDITIONAL INFORMATION RECEIVED: BDJ RECEIVED AN ACTUAL USED SAMPLE AND THE NEEDLE WAS HALF RETRACTED. THE TIP OF NEEDLE WAS EXISTED OUT OF BARREL. THE PUSHING BUTTON WASN'T MOVED AND LOOKED BROKEN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672278 BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 367344 9162776 50382903673440

    Patients

    Seq Age Sex Outcome Treatment
    1