BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN

    MDR report key: 8819459 · Received July 23, 2019

    Report

    Report Number
    2243072-2019-01488
    Event Type
    Malfunction
    Date Received
    July 23, 2019
    Date of Event
    July 9, 2019
    Report Date
    September 20, 2019
    Manufacturer
    BECTON DICKINSON
    Product Code
    JKA
    UDI-DI
    50382903687744
    PMA / PMN Number
    K101502
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD RECEIVED CONTAMINATED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR POOR WITH THE INCIDENT LOT WAS NOT OBSERVED. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS GEL MIGRATION DURING USE WITH A BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: GEL MIGRATION CONCERNS WITH RST CENTRIFUGATION: BIOMED INVESTIGATED THAT THE CENTRIFUGE WAS WORKING PROPERLY EPPENDORF 5804, 1300 10 MIN TECH SAID THEY LET SAMPLE CLOT.

    Additional Manufacturer Narrative · 1

    FOR OEM MANUFACTURING SITES: IN THIS MDR, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AS (B)(4) IS AN OEM MANUFACTURING SITE. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS GEL MIGRATION DURING USE WITH A BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: GEL MIGRATION CONCERNS WITH RST. CENTRIFUGATION: BIOMED INVESTIGATED THAT THE CENTRIFUGE WAS WORKING PROPERLY. EPPENDORF 5804, 1300 10 MIN. TECH SAID THEY LET SAMPLE CLOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609419 BD VACUTAINER® RAPID SERUM TUBE (RST) BLOOD COLLECTION TUBES THROMBIN BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON UNKNOWN 50382903687744

    Patients

    Seq Age Sex Outcome Treatment
    1 Other