BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 18426928 · Received January 2, 2024

    Report

    Report Number
    1024879-2023-00935
    Event Type
    Malfunction
    Date Received
    January 2, 2024
    Date of Event
    December 11, 2023
    Report Date
    April 8, 2024
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903673648
    PMA / PMN Number
    K212724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D9: DEVICE AVAILABLE FOR EVALUATION: YES D.9:DEVICE EVAL BY MANUFACTURER? YES D9: RETURNED TO MANUFACTURER ON: 2024-JANUARY- 15TH H.6 INVESTIGATION SUMMARY MATERIAL #: 367364 LOT/BATCH #: 2202065 BD RECEIVED 2 SAMPLES AND 1 PHOTO FOR INVESTIGATION. THE PHOTO SHOWS THE PRODUCT PACKAGING, CONFIRMING THE LOT NUMBER. ADDITIONALLY, THE CUSTOMER SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR PREACTIVATION WITH THE INCIDENT LOT WAS NOT OBSERVED. THE CUSTOMER SAMPLES WERE ALSO EVALUATED BY FUNCTIONAL TESTING AND THE INDICATED FAILURE MODE UNABLE TO RETRACT WAS OBSERVED IN BOTH SAMPLES. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE UNABLE TO RETRACT. THIS COMPLAINT COULD NOT BE CONFIRMED FOR PREACTIVATION. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED.

    Additional Manufacturer Narrative · 0

    D.1 MEDICAL DEVICE TYPE: FPA, JKA. H.3. 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 · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET THAT THE RETRACTING BEFORE THE PACKAGE IS OPEN OR FAILING TO RETRACT AFTER USE ON A PATIENT CREATING A NEEDLE STICK RISK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET THAT THE RETRACTING BEFORE THE PACKAGE IS OPEN OR FAILING TO RETRACT AFTER USE ON A PATIENT CREATING A NEEDLE STICK RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1451209 BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET JKA BECTON, DICKINSON & CO., (BD) 2202065 50382903673648

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown