BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SST BLOOD COLLECTION TUBES

    MDR report key: 10994435 · Received December 12, 2020

    Report

    Report Number
    1024879-2020-00923
    Event Type
    Malfunction
    Date Received
    December 12, 2020
    Date of Event
    November 1, 2020
    Report Date
    January 4, 2021
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679862
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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: 2020-12-04. INVESTIGATION SUMMARY: BD RECEIVED 6 SAMPLES FROM THE CUSTOMER FOR INVESTIGATION. ALL SAMPLES WERE EVALUATED BY VISUAL EXAMINATION AND THE INDICATED FAILURE MODE FOR LOW/ NO DRAW, FM EMBEDDED IN THE TUBE, FM IN GEL AND FM IN THE TUBE 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. BD IS REVIEWING SPECIFIC AREAS IN THE MANUFACTURING PROCESS RELATING TO THE UNDERFILL ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES EXPERIENCED UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD AND FOREIGN MATTER IN TUBE BIOLOGICAL AND NON-BIOLOGICAL. THIS UNDERFILL EVENT OCCURRED 4 TIMES. THIS FOREIGN MATTER EVENT OCCURRED 4 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRANSLATED TO ENGLISH. THE CUSTOMER STATED "WHEN USING THE TUBE,IT FOUND THAT THERE WAS FOREIGN MATTER IN THE TUBE AND HAS LOW DRAW ISSUE."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0029294, MEDICAL DEVICE EXPIRATION DATE: 2021-01-31, DEVICE MANUFACTURE DATE: (B)(6) 2020. MEDICAL DEVICE LOT #: 0051817, MEDICAL DEVICE EXPIRATION DATE: 2021-02-28, DEVICE MANUFACTURE DATE: (B)(6) 2020. MEDICAL DEVICE LOT #: 0017566, MEDICAL DEVICE EXPIRATION DATE: 2021-01-31, DEVICE MANUFACTURE DATE: (B)(6) 2020. MEDICAL DEVICE LOT #: 0140158, MEDICAL DEVICE EXPIRATION DATE: 2021-05-31, DEVICE MANUFACTURE DATE: (B)(6) 2020. 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 THE BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES EXPERIENCED UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD AND FOREIGN MATTER IN TUBE BIOLOGICAL AND NON-BIOLOGICAL. THIS UNDERFILL EVENT OCCURRED 4 TIMES. THIS FOREIGN MATTER EVENT OCCURRED 4 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRANSLATED TO ENGLISH. THE CUSTOMER STATED "WHEN USING THE TUBE,IT FOUND THAT THERE WAS FOREIGN MATTER IN THE TUBE AND HAS LOW DRAW ISSUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459551 BD VACUTAINER SST BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367986 SEE H.10 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1