BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 7601655 · Received June 14, 2018

    Report

    Report Number
    2243072-2018-01206
    Event Type
    Malfunction
    Date Received
    June 14, 2018
    Date of Event
    March 28, 2018
    Report Date
    November 13, 2019
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT ON TWO OCCASIONS A BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAD HIGH CRITICAL TEST RESULTS FOR BYN + CREATIN. PATIENT IDENTIFIERS WERE NOT RECEIVED AS PART OF THE COMPLAINT. MEDICAL DEVICE BRAND NAME: BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES. MEDICAL DEVICE TYPE: JKA. COMMON DEVICE NAME: BLOOD SPECIMEN COLLECTION DEVICE. MEDICAL DEVICE MANUFACTURER: BECTON, DICKINSON & CO., (BD). MEDICAL DEVICE CATALOG #: 367983. MEDICAL DEVICE LOT #: 8018694. MEDICAL DEVICE EXPIRATION DATE: 01/31/2019. UNIQUE IDENTIFIER (UDI) #: (B)(4). MANUFACTURING LOCATION: BECTON, DICKINSON & CO., (BD) PMA / 510(K)#: BK050036. DEVICE MANUFACTURE DATE: (B)(6)2018. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE POSSIBLE 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. NOTE THAT THE CUSTOMER HAD INDICATED THAT CATALOG #367983, LOT #8018694 WAS POSSIBLE LOT NUMBER BUT WAS NOT CERTAIN OF THIS. FURTHERMORE, BD TECHNICAL SERVICES HAD PROVIDED TROUBLESHOOTING, SPECIFIC TO THE PROCESSING AND CLOTTING INFORMATION REQUESTED BY THE CUSTOMER REGARDING THEIR ISSUE. BD WILL CONTINUE TO MONITOR FOR ADDITIONAL COMPLAINTS AND EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON TWO OCCASIONS A BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES HAD HIGH CRITICAL TEST RESULTS FOR BYN + CREATIN. PATIENT IDENTIFIERS WERE NOT RECEIVED AS PART OF THE COMPLAINT.

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INITIAL REPORTER: ADDRESS UNAVAILABLE. BD CORPORATE ADDRESS USED. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. 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 · 1

    IT WAS REPORTED THAT AN UNSPECIFIED BD VACUTAINER® HAD HIGH CRITICAL TEST RESULTS FOR BYN + CREATIN. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442527 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 8018694

    Patients

    Seq Age Sex Outcome Treatment
    1 Other