BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 17209740 · Received June 27, 2023

    Report

    Report Number
    1024879-2023-00409
    Event Type
    Malfunction
    Date Received
    June 27, 2023
    Date of Event
    June 1, 2023
    Report Date
    November 9, 2023
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903673648
    PMA / PMN Number
    K212724
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL/CORRECTED INFORMATION: B.1. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET IS LEAKING WHEN THE NEEDLE RETRACTS AND SPLATTERING BLOOD ON THE TECHNICIAN. EMPLOYEES WERE WEARING PPE SO NO EXPOSURE OCCURRED. H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT 3 PHOTOS WERE PROVIDED FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR LEAKAGE WAS OBSERVED. ADDITIONALLY, 30 RETENTION SAMPLES OF EACH REPORTED LOT NUMBER (60 TOTAL) FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL DRAW AND RETRACTION TESTING AND THE ISSUE OF SPLATTER / LEAKAGE WAS NOT OBSERVED. 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 LEAKAGE. 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. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS."

    Additional Manufacturer Narrative · 0

    D.2. MEDICAL DEVICE TYPE. THIS PRODUC THAS TWO CODES JKA AND FPA. THERE WERE TWO LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 3013896. D4. MEDICAL DEVICE EXPIRATION DATE: 31 JAN 2025. H4. DEVICE MANUFACTURE DATE: 13 JAN 2023. H3. 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 BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET IS LEAKING WHEN THE NEEDLE RETRACTS AND SPLATTERING BLOOD ON THE TECHNICIAN. EMPLOYEES WERE WEARING PPE SO NO EXPOSURE OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS A CONSTANT ISSUE WITH WINGSETS LEAKING WHEN THE NEEDLE RETRACTS AND SPLASHING BLOOD ON THE TEAM MEMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET IS LEAKING WHEN THE NEEDLE RETRACTS AND SPLATTERING BLOOD ON THE TECHNICIAN. IF EXPOSURE OCCURRED WAS THERE ANY POST EXPOSURE TESTING OR MEDICAL INTERVENTION? PENDING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS A CONSTANT ISSUE WITH WINGSETS LEAKING WHEN THE NEEDLE RETRACTS AND SPLASHING BLOOD ON THE TEAM MEMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1453255 BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET BLOOD SPECIMEN COLLECTION DEVICE; INTRAVASCULAR ADMINISTRATION SET JKA BECTON, DICKINSON & CO., (BD) 367364 2318149 50382903673648

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown