BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 9272873 · Received November 4, 2019

    Report

    Report Number
    1024879-2019-01907
    Event Type
    Malfunction
    Date Received
    November 4, 2019
    Date of Event
    October 16, 2019
    Report Date
    December 13, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903679862
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BASED ON RESULTS OF THE R&D TESTING IN (B)(6) THE INDICATED FAILURE MODE FOR STOPPER PULLOUT WITH THE INCIDENT LOT WAS OBSERVED. NO ADDITIONAL TESTING CAN BE PERFORMED AT THE MANUFACTURING SITE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING R&D TESTING THE STOPPER REMOVAL FORCES DID NOT MEET THE MINIMUM AND/OR MEAN FORCE SPECIFICATION WITH A BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING R&D TESTING IN (B)(4), WE OBSERVED SOME TUBES WITH 2ND TIME STOPPER REMOVAL FORCES THAT DID NOT MEET THE MINIMUM AND/OR MEAN FORCE SPECIFICATION. THE PRODUCT INFORMATION IS LISTED BELOW. CATALOG #, BATCH #, TEST DATE, DATA REVIEW DATE, OBSERVATION: 367986, 9081743, 16 OCT 2019, 17 OCT 2019, DID NOT MEET MINIMUM FORCE SPECIFICATION. 9081745, 16 OCT 2019, 17 OCT 2019, DID NOT MEET MINIMUM OR MEAN FORCE SPECIFICATION. 9093690, 16 OCT 2019, 17 OCT 2019, DID NOT MEET MINIMUM OR MEAN FORCE SPECIFICATION.

    Additional Manufacturer Narrative · 1

    "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9081743 . MEDICAL DEVICE EXPIRATION DATE: 2020-03-31. DEVICE MANUFACTURE DATE: 2019-03-22. MEDICAL DEVICE LOT #: 9081745. MEDICAL DEVICE EXPIRATION DATE: 2020-03-31. DEVICE MANUFACTURE DATE: 2019-03-22. MEDICAL DEVICE LOT #: 9093690. MEDICAL DEVICE EXPIRATION DATE: 2020-03-31. DEVICE MANUFACTURE DATE: 2019-04-03." A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING R&D TESTING THE STOPPER REMOVAL FORCES DID NOT MEET THE MINIMUM AND/OR MEAN FORCE SPECIFICATION WITH A BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING R&D TESTING IN FRANKLIN LAKES, WE OBSERVED SOME TUBES WITH 2ND TIME STOPPER REMOVAL FORCES THAT DID NOT MEET THE MINIMUM AND/OR MEAN FORCE SPECIFICATION. THE PRODUCT INFORMATION IS LISTED BELOW. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065106 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) SEE H.10 50382903679862

    Patients

    Seq Age Sex Outcome Treatment
    1 Other