BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 18614547 · Received January 31, 2024

    Report

    Report Number
    1024879-2024-00072
    Event Type
    Malfunction
    Date Received
    January 31, 2024
    Date of Event
    January 11, 2024
    Report Date
    February 9, 2024
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679862
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: D4: MEDICAL DEVICE LOT #: 3160660. D4: MEDICAL DEVICE EXPIRATION DATE: 2024-06-30. H4: DEVICE MANUFACTURE DATE: 2023-06-09. E1: INITIAL REPORTER ADDRESS 1: (B)(6). E1: INITIAL REPORTER ADDRESS 2: (B)(6). E1: INITIAL REPORTER ZIP: (B)(6). H6: INVESTIGATION SUMMARY: BD RECEIVED FOUR (4) SAMPLES AND TWO (2) PHOTOS FOR INVESTIGATION. THE PHOTOS WERE REVIEWED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR EMBEDDED FOREIGN MATTER WAS OBSERVED. ADDITIONALLY, THE CUSTOMER SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR EMBEDDED FOREIGN MATTER WITH THE INCIDENT LOT WAS OBSERVED. 4 CUSTOMER SAMPLE WAS SUBJECTED TO A VISUAL INSPECTION FOR EMBEDDED FM. 1 OF 4 CUSTOMER SAMPLES FAILED. 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 EMBEDDED FOREIGN MATTER. 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

    D4. MEDICAL DEVICE LOT#: UNKNOWN. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. H4. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THERE WERE DARK PARTICLES FOUND INSIDE OF AN UNSPECIFIED NUMBER OF TUBES. NO PATIENT IMPACT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, THERE WERE DARK PARTICLES FOUND INSIDE OF AN UNSPECIFIED NUMBER OF TUBES. NO PATIENT IMPACT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1261900 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 3160660 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown