BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 9444195 · Received December 10, 2019

    Report

    Report Number
    1024879-2019-02095
    Event Type
    Malfunction
    Date Received
    December 10, 2019
    Date of Event
    October 21, 2019
    Report Date
    February 25, 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

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. 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 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 IS NOT RETRACTING AND THERE WAS BLOOD SPLATTER. THIS WAS DISCOVERED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367364, BATCH NO. 9021874 (2 OF 3). -IT IS REPORTED CUSTOMER EXPERIENCED ISSUES WITH WINGSET NOT RETRACTING AND BLOOD SPLATTER. UNSAFE, NEEDLE DID NOT RETRACT, BLOOD SPLATTERS WHEN WITHDRAWING NEEDLE FROM VEIN.

    Additional Manufacturer Narrative · 1

    ADDITIONAL MEDICAL DEVICE TYPE: FPA. ADDITIONAL COMMON DEVICE NAME: INTRAVASCULAR ADMINISTRATION SET. 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 IS NOT RETRACTING AND THERE WAS BLOOD SPLATTER. THIS WAS DISCOVERED AFTER USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367364, BATCH NO. 9021874 (2 OF 3). IT IS REPORTED CUSTOMER EXPERIENCED ISSUES WITH WINGSET NOT RETRACTING AND BLOOD SPLATTER. UNSAFE, NEEDLE DID NOT RETRACT, BLOOD SPLATTERS WHEN WITHDRAWING NEEDLE FROM VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243464 BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367364 9021874 50382903673648

    Patients

    Seq Age Sex Outcome Treatment
    1 Other