BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 8845974 · Received July 31, 2019

    Report

    Report Number
    1024879-2019-01306
    Event Type
    Malfunction
    Date Received
    July 31, 2019
    Date of Event
    April 30, 2019
    Report Date
    September 17, 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: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. 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 AN UNSPECIFIED NUMBER OF BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES EXPERIENCED DIFFICULTY REMOVING THE STOPPER PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367986, BATCH NO. 9081743, 9081745, 9093690. IT WAS REPORTED THAT THE 2ND STOPPER PULLOUT FORCE FOR SOME TUBES DID NOT MEET OUR SPECIFICATIONS. 367986, 9081743, MINIMUM FORCE BELOW SPECIFICATION. 367986, 9081745, MEAN FORCE & MINIMUM FORCE BELOW SPECIFICATION. 367986, 9093690, MEAN FORCE & MINIMUM FORCE BELOW SPECIFICATION.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES EXPERIENCED DIFFICULTY REMOVING THE STOPPER PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 367986. BATCH NO. 9081743, 9081745, 9093690. IT WAS REPORTED THAT THE 2ND STOPPER PULLOUT FORCE FOR SOME TUBES DID NOT MEET OUR SPECIFICATIONS. 367986, 9081743, MINIMUM FORCE BELOW SPECIFICATION. 367986, 9081745, MEAN FORCE & MINIMUM FORCE BELOW SPECIFICATION. 367986, 9093690, MEAN FORCE & MINIMUM FORCE BELOW SPECIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639595 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