BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 9281097 · Received November 5, 2019

    Report

    Report Number
    1024879-2019-01917
    Event Type
    Injury
    Date Received
    November 5, 2019
    Date of Event
    October 16, 2019
    Report Date
    January 28, 2020
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903673648
    PMA / PMN Number
    K153309
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR RETRACTION FAILURE WITH THE INCIDENT LOT WAS NOT OBSERVED. TESTING OF THE CUSTOMER SAMPLES WAS PERFORMED AND RETRACTION FAILURE WAS NOT OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT 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. BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH CAPA 891355 AND POTENTIAL CAUSES HAVE BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS HAVE BEEN ESTABLISHED AND IMPLEMENTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SETS EXPERIENCED RETRACTION ISSUES -WOULD NOT RETRACT. THIS DEFECT RESULTED IN A NEEDLE STICK INJURY TO THE DEVICE OPERATOR. IT WAS REPORTED THAT "BLOODWORK" WAS DONE ON BOTH THE SOURCE PATIENT AND DEVICE OPERATOR. THE RESULTS OF THE BLOODWORK HAVE NOT BEEN PROVIDED. FOLLOW UP CARE WAS ALSO SOUGHT, THOUGH IT IS NOT SPECIFIED WHAT IT ENTAILED OR WHAT THE RESULTS WERE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367364, BATCH NO. 9021874.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE TYPE: JKA, FPA. 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 THAT 2 BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SETS EXPERIENCED RETRACTION ISSUES -WOULD NOT RETRACT. THIS DEFECT RESULTED IN A NEEDLE STICK INJURY TO THE DEVICE OPERATOR. IT WAS REPORTED THAT "BLOODWORK" WAS DONE ON BOTH THE SOURCE PATIENT AND DEVICE OPERATOR. THE RESULTS OF THE BLOODWORK HAVE NOT BEEN PROVIDED. FOLLOW UP CARE WAS ALSO SOUGHT, THOUGH IT IS NOT SPECIFIED WHAT IT ENTAILED OR WHAT THE RESULTS WERE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367364 BATCH NO. 9021874 . PER EMAIL: WE HAD TWO CASES THIS MORNING WHERE A BUTTERFLY NEEDLE DID NOT RETRACT PROPERLY. IN BOTH, WHEN THE BUTTON WAS PRESSED THE NEEDLE RETRACTED BUT THEN IT SPRANG BACK OUT (TO ABOUT HALF WAY)ONCE IT WAS PULLED AWAY FROM THE PATIENT. ONE WAS A NEAR MISS. THE OTHER WAS A NEEDLE STICK FOR OUR EMPLOYEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1072167 BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET JKA BECTON, DICKINSON & CO., (BD) 367364 9021874 50382903673648

    Patients

    Seq Age Sex Outcome Treatment
    1 Other