BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 9695480 · Received February 11, 2020

    Report

    Report Number
    1024879-2020-00084
    Event Type
    Malfunction
    Date Received
    February 11, 2020
    Date of Event
    August 16, 2019
    Report Date
    April 13, 2020
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679770
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY : BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR FOREIGN MATTER WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, EVALUATION OF THE CUSTOMER SAMPLES WAS PERFORMED AND FOREIGN MATTER WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND BEFORE USE WITH A BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "FM GOT MIXED."

    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 #: 9213247. MEDICAL DEVICE EXPIRATION DATE: 2020-05-31. DEVICE MANUFACTURE DATE: 2019-08-01. MEDICAL DEVICE LOT #: 9270319. MEDICAL DEVICE EXPIRATION DATE: 2020-07-31. DEVICE MANUFACTURE DATE: 2019-09-27. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND BEFORE USE WITH A BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "FM GOT MIXED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160375 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 367977 SEE. H.10 50382903679770

    Patients

    Seq Age Sex Outcome Treatment
    1 Other