BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 8883010 · Received August 12, 2019

    Report

    Report Number
    1710034-2019-00872
    Event Type
    Malfunction
    Date Received
    August 12, 2019
    Date of Event
    July 22, 2019
    Report Date
    September 9, 2019
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    JKA
    UDI-DI
    50382903673440
    PMA / PMN Number
    K030573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE TESTED/EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR TUBE PUSH OFF WITH THE INCIDENT LOTS WAS NOT OBSERVED AS ALL PRODUCT SPECIFICATIONS WERE MET. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOTS AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 0

    MATERIAL NO. 367344 BATCH NO. 9108806 AND 9102949. IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THE TUBES POP OFF EASILY REQUIRING A GREAT AMOUNT OF FORCE TO HOLD IN PLACE TO AVOID THE ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TUBES ATTACHED TO BUTTERFLY COLLECTION SET POP OFF EASILY, STOPPING BLOOD FLOW. IT IS RESULTING IN ( ) WASTE AND NEED TO RESTICK PATIENTS. PHLEBOTOMIST STATE IT FEELS AS TOUGH TUBE MUST BE HELD IN PLACE W/ A GREAT AMOUNT OF FORCE TO AVOID ISSUES.

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9108806. MEDICAL DEVICE EXPIRATION DATE: 2021-04-30. DEVICE MANUFACTURE DATE: 2019-05-09. MEDICAL DEVICE LOT #: 9102949. MEDICAL DEVICE EXPIRATION DATE: 2021-04-30. DEVICE MANUFACTURE DATE: 2019-05-02. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO. 367344, BATCH NO. 9108806 AND 9102949. IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET THE TUBES POP OFF EASILY REQUIRING A GREAT AMOUNT OF FORCE TO HOLD IN PLACE TO AVOID THE ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "TUBES ATTACHED TO BUTTERFLY COLLECTION SET POP OFF EASILY, STOPPING BLOOD FLOW. IT IS RESULTING IN ( ) WASTE AND NEED TO RESTICK PATIENTS. PHLEBOTOMIST STATE IT FEELS AS TOUGH TUBE MUST BE HELD IN PLACE W/ A GREAT AMOUNT OF FORCE TO AVOID ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678921 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. SEE H.10 50382903673440

    Patients

    Seq Age Sex Outcome Treatment
    1 Other