BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SST BLOOD COLLECTION TUBES

    MDR report key: 11120353 · Received January 5, 2021

    Report

    Report Number
    1024879-2021-00004
    Event Type
    Malfunction
    Date Received
    January 5, 2021
    Date of Event
    December 11, 2020
    Report Date
    January 28, 2021
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 1/5/2021. H.6. INVESTIGATION: BD RECEIVED 6 SAMPLES FROM THE CUSTOMER FOR INVESTIGATION. THE SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR FM IN GEL WITH THE INCIDENT LOT WAS 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USE WITH BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES FOREIGN MATTER WAS DISCOVERED IN GEL OF 6 TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE FOLLOWING ISSUE WAS FOUND IN TUBES (367991) FROM LOT 0232230: FM IN GEL ×6.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO USE WITH BD VACUTAINER(R) SST" BLOOD COLLECTION TUBES FOREIGN MATTER WAS DISCOVERED IN GEL OF 6 TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE FOLLOWING ISSUE WAS FOUND IN TUBES (367991) FROM LOT 0232230: FM IN GEL X6.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15545 BD VACUTAINER SST BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 0232230

    Patients

    Seq Age Sex Outcome Treatment
    1