BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 8970323 · Received September 6, 2019

    Report

    Report Number
    1024879-2019-01585
    Event Type
    Malfunction
    Date Received
    September 6, 2019
    Date of Event
    August 20, 2019
    Report Date
    October 7, 2019
    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 AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR PARTIAL RETRACTION WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, EVALUATION/TESTING OF THE CUSTOMER SAMPLES WAS PERFORMED AND PARTIAL RETRACTION 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 A CAPA #891355 AND POTENTIAL CAUSES HAVE BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS HAVE BEEN ESTABLISHED AND ARE IN THE PROCESS OF BEING IMPLEMENTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET HAD RETRACTION ISSUES. THIS OCCURRED ON 3 OCCASIONS AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367364, BATCH NO. 8323625, 8211828 AND 8309855. IT WAS REPORTED NEEDLE ONLY PARTIALLY RETRACTED WHEN WINGSET PUSH BUTTON WAS ACTIVATED. ACTIVATING THE SAFETY BUTTON SHOULD RETRACT THE NEEDLE INTO THE HOUSING. WHEN THE SAFETY BUTTON WAS PRESSED THE NEEDLE ONLY PARTIALLY RETRACTED INTO THE HOUSING THUS BECOMING A SAFETY RISK.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MEDICAL DEVICE TYPE: FPA. ADDITIONAL COMMON DEVICE NAME: INTRAVASCULAR ADMINISTRATION SET. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8323625. MEDICAL DEVICE EXPIRATION DATE: 2020-11-30. DEVICE MANUFACTURE DATE: 2018-11-19. MEDICAL DEVICE LOT #: 8211828. MEDICAL DEVICE EXPIRATION DATE: 2020-07-31. DEVICE MANUFACTURE DATE: 2018-07-30. MEDICAL DEVICE LOT #: 8309855. MEDICAL DEVICE EXPIRATION DATE: 2020-10-31. DEVICE MANUFACTURE DATE: 2018-11-05. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET HAD RETRACTION ISSUES. THIS OCCURRED ON 3 OCCASIONS AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367364, BATCH NO. 8323625, 8211828 AND 8309855. IT WAS REPORTED NEEDLE ONLY PARTIALLY RETRACTED WHEN WINGSET PUSH BUTTON WAS ACTIVATED. ACTIVATING THE SAFETY BUTTON SHOULD RETRACT THE NEEDLE INTO THE HOUSING. WHEN THE SAFETY BUTTON WAS PRESSED THE NEEDLE ONLY PARTIALLY RETRACTED INTO THE HOUSING THUS BECOMING A SAFETY RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764741 BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) SEE H.10 50382903673648

    Patients

    Seq Age Sex Outcome Treatment
    1 Other