BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 15433249 · Received September 15, 2022

    Report

    Report Number
    9617032-2022-00896
    Event Type
    Injury
    Date Received
    September 15, 2022
    Date of Event
    August 9, 2022
    Report Date
    October 14, 2022
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903673648
    PMA / PMN Number
    K153309
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE MEDICAL DEVICE TYPES REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH 510(K) NUMBER IS AS FOLLOWS: COMMON DEVICE NAME: INTRAVASCULAR ADMINISTRATION SET. MEDICAL DEVICE TYPE: FPA. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: CATALOG NUMBER: 367364, BATCH NUMBER: 2151451. NO CUSTOMER PHOTOS OR SAMPLES WERE RECEIVED FOR REVIEW AND EVALUATION. AS NO CUSTOMER PHOTOS OR SAMPLES WERE RECEIVED THE SCOPE OF THIS INVESTIGATION IS LIMITED. THEREFORE, 30 RETAIN SAMPLES FROM THE BD INVENTORY WERE SUBJECTED TO A DRAW TEST. ALL THE RETAIN SAMPLES PASSED WITH NO EVIDENCE OF LEAKAGE OR SEPARATION. THEREFORE, THIS COMPLAINT CANNOT BE CONFIRMED FOR SEPARATES DURING USE BASED ON THE RETAIN SAMPLE DRAW TESTING RESULTS. BD IS UNABLE TO CONFIRM THE CUSTOMER¿S REPORTED FAILURE MODE OF SEPARATES DURING USE AND NEEDLE STICK ¿ AFTER USE/DIRTY BASED ON RETAIN SAMPLE ANALYSIS TESTING RESULTS. THE DEVICE HISTORY RECORD WAS REVIEWED WITH NO ISSUES BEING IDENTIFIED. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. BD WAS UNABLE TO DETERMINE A ROOT CAUSE FOR THE CUSTOMER'S INDICATED ISSUE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET THERE WAS NON PATIENT NEEDLE SEPARATION FROM THE HOLDER LUER/ADAPTOR/HUB AND A NEEDLE STICK INJURY - POST USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "A COLLECTION STAFF MEMBER TRIED TO REMOVE THE LUER END WITH BARREL OF THE DEVICE FROM A PUSH BUTTON BLOOD COLLECTION WINGSET TO TAKE A VENOUS BLOOD GAS. ONLY THE BARREL REMOVED AND THE LUER END WAS EXPOSED AND THE STAFF MEMBER ALMOST SUSTAINED A NEEDLE STICK INJURY." UPDATED ENTRY DESCRIPTION (B)(6) 2022: CUSTOMER CONFIRMED NEEDLE STICK INJURY OCCURRED. SOUGHT MEDICAL INTERVENTION HOWEVER NO TREATMENT WAS REQUIRED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET THERE WAS NON PATIENT NEEDLE SEPARATION FROM THE HOLDER LUER/ADAPTOR/HUB AND A NEEDLE STICK INJURY - POST USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "A COLLECTION STAFF MEMBER TRIED TO REMOVE THE LUER END WITH BARREL OF THE DEVICE FROM A PUSH BUTTON BLOOD COLLECTION WINGSET TO TAKE A VENOUS BLOOD GAS. ONLY THE BARREL REMOVED AND THE LUER END WAS EXPOSED AND THE STAFF MEMBER ALMOST SUSTAINED A NEEDLE STICK INJURY." UPDATED ENTRY DESCRIPTION 07 SEP 2022: CUSTOMER CONFIRMED NEEDLE STICK INJURY OCCURRED. SOUGHT MEDICAL INTERVENTION HOWEVER NO TREATMENT WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1651854 BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 367364 2151451 50382903673648

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention