BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER

    MDR report key: 22834166 · Received August 18, 2025

    Report

    Report Number
    1024879-2025-01119
    Event Type
    Malfunction
    Date Received
    August 18, 2025
    Date of Event
    July 22, 2025
    Report Date
    January 30, 2026
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    30382903673002
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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

    INVESTIGATION SUMMARY: BD RECEIVED THREE PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE FOR SLEEVE SIDE PIERCING/RECOVERY WAS OBSERVED. ADDITIONALLY, 10 RETENTION SAMPLES PER BATCH NUMBER (4275465, 4163205, AND 5029449) WERE SUBJECTED TO SLEEVE FUNCTION TESTING AND THE ISSUE OF SLEEVE SIDE PIERCING/RECOVERY 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 SLEEVE SIDE PIERCING/RECOVERY BASED ON CUSTOMER PHOTO ANALYSIS. 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.

    Description of Event or Problem · 0

    REPORT 2 OF 3. IT WAS REPORTED WHILE USING BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER, THE NEEDLE PIERCES THE SIDE OF THE SLEEVE RESULTING IN SAMPLE LEAKAGE. THIS HAS OCCURRED IN AN UNSPECIFIED NUMBER OF DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    REPORT 2 OF 3, IT WAS REPORTED WHILE USING BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER, THE NEEDLE PIERCES THE SIDE OF THE SLEEVE RESULTING IN SAMPLE LEAKAGE. THIS HAS OCCURRED IN AN UNSPECIFIED NUMBER OF DEVICES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2043983 BD VACUTAINER® MULTIPLE SAMPLE LUER ADAPTER BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 4163205 30382903673002

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown