BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿

    MDR report key: 22097765 · Received May 28, 2025

    Report

    Report Number
    1024879-2025-00739
    Event Type
    Malfunction
    Date Received
    May 28, 2025
    Date of Event
    April 30, 2025
    Report Date
    August 1, 2025
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    30382903679837
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. D9: DEVICE AVAILABLE FOR EVALUATION: YES. D9: RETURNED TO MANUFACTURER ON 21-MAY-2025. INVESTIGATION SUMMARY: BD RECEIVED TWO PHOTOS AND ONE SAMPLE FOR INVESTIGATION. THE SAMPLE WAS CONTAMINATED WITH BLOOD AND COULD NOT BE TESTED. THE PHOTOS WERE EVALUATED AND SHOW A RUBBER STOPPER AND A TUBE WITH A SMALL AMOUNT OF BLOOD HOWEVER, THE SPECIMEN CONTAINING TUBE WAS NOT LABELED IN A WAY THAT COULD IDENTIFY WHICH LOT THE TUBE BELONGED TO. ADDITIONALLY, A TOTAL OF (B)(4) RETAINED SAMPLES FROM BATCH 4220031 UNDERWENT FUNCTIONAL TESTS, AND ALL TUBES WERE WITHIN SPECIFICATION. LASTLY, 30 RETAINED SAMPLES FROM BATCH 4220031 WERE VISUALLY INSPECTED WITH NO FAILURES NOTED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOTS, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE INDICATED FAILURE MODES: UNDERFILL AND OTHER. 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 THE IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    E1. INITIAL REPORTER PHONE #: (B)(6). E1. INITIAL REPORTER FACILITY NAME: (B)(6). THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION IS AS FOLLOWS: G.4. PMA / 510(K)#: K230855. 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 WHILE USING BD VACUTAINER® SST¿, INABILITY TO PUNCTURE THE RUBBER STOPPER AND UNDERFILL ARE SEEN IN AN UNSPECIFIED NUMBER OF TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿, INABILITY TO PUNCTURE THE RUBBER STOPPER AND UNDERFILL ARE SEEN IN AN UNSPECIFIED NUMBER OF TUBES. NO ADVERSE IMPACT WAS REPORTED REGARDING THE PATIENT OR USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361931 BD VACUTAINER® SST¿ BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 4220031 30382903679837

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown