BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SST BLOOD COLLECTION TUBES

    MDR report key: 11065997 · Received December 23, 2020

    Report

    Report Number
    1024879-2020-00945
    Event Type
    Malfunction
    Date Received
    December 23, 2020
    Date of Event
    November 25, 2020
    Report Date
    January 4, 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: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2020-12-09. INVESTIGATION SUMMARY: BD RECEIVED 1 SAMPLE FROM THE CUSTOMER FOR INVESTIGATION. THE SAMPLE WAS EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR FM IN GEL WITH THE INCIDENT LOT WAS OBSERVED. THE BLACK FM IN THE TUBE APPEARS TO BE A PIECE OF BURNT SILICA. BD REVIEWED SPECIFIC AREAS IN THE MANUFACTURING PROCESS RELATING TO THIS ISSUE AND IMPROVEMENTS WERE MADE AS A RESULT. 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 NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE FOLLOWING ISSUE WAS FOUND IN TUBE (367997) FROM LOT 0232231: FM IN GEL ×1".

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER SST BLOOD COLLECTION TUBES CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE FOLLOWING ISSUE WAS FOUND IN TUBE (367997) FROM LOT 0232231: FM IN GEL ×1".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1531934 BD VACUTAINER SST BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 0232231

    Patients

    Seq Age Sex Outcome Treatment
    1