BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER SODIUM HEPARINN (NH) 158 USP UNITS BLOOD COLLECTION TUBES

    MDR report key: 10708285 · Received October 20, 2020

    Report

    Report Number
    1917413-2020-00968
    Event Type
    Malfunction
    Date Received
    October 20, 2020
    Date of Event
    September 29, 2020
    Report Date
    November 5, 2020
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903678742
    PMA / PMN Number
    K945952
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. 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. THE CUSTOMER INDICATED THAT IT APPEARED TO BE CAUSED BY A COLLECTION ERROR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE ADDITIVE WAS ABNORMAL WITH A BD VACUTAINER® SODIUM HEPARINN (NH) 158 USP UNITS BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER SAYS THE LAB TECH STATED THAT WHEN THEY ARE PROCESSING THEIR SAMPLES, THE TUBES ARE GEL LIKE AND HARD. ADDITIONALLY, ON 2020-10-02 THE CUSTOMER PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: AFTER FURTHER INVESTIGATION INTO THE SITUATION, IT WAS DETERMINED THAT IT WAS SITE COLLECTION ERROR. THE BLOOD WAS DRAWN IN A SYRINGE AND WAS CLOTTING EVEN BEFORE THEY ATTEMPTED TO TRANSFER IT TO THE VACUTAINER TUBE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9220473, MEDICAL DEVICE EXPIRATION DATE: 2021-08-31, DEVICE MANUFACTURE DATE: 2019-08-08, MEDICAL DEVICE LOT #: 9344985, MEDICAL DEVICE EXPIRATION DATE: 2021-12-31, DEVICE MANUFACTURE DATE: 2019-12-10. 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 THAT THE ADDITIVE WAS ABNORMAL WITH A BD VACUTAINER® SODIUM HEPARINN (NH) 158 USP UNITS BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER SAYS THE LAB TECH STATED THAT WHEN THEY ARE PROCESSING THEIR SAMPLES, THE TUBES ARE GEL LIKE AND HARD. ADDITIONALLY, ON 2020-10-02 THE CUSTOMER PROVIDED THE FOLLOWING ADDITIONAL INFORMATION: AFTER FURTHER INVESTIGATION INTO THE SITUATION, IT WAS DETERMINED THAT IT WAS SITE COLLECTION ERROR. THE BLOOD WAS DRAWN IN A SYRINGE AND WAS CLOTTING EVEN BEFORE THEY ATTEMPTED TO TRANSFER IT TO THE VACUTAINER TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1173774 BD VACUTAINER SODIUM HEPARINN (NH) 158 USP UNITS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 367874 SEE H.10 50382903678742

    Patients

    Seq Age Sex Outcome Treatment
    1