BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER CPT CELL PREPARATION TUBE WITH SODIUM HEPARIN

    MDR report key: 11142193 · Received January 8, 2021

    Report

    Report Number
    1917413-2021-00009
    Event Type
    Malfunction
    Date Received
    January 8, 2021
    Date of Event
    December 21, 2020
    Report Date
    January 22, 2021
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903627535
    PMA / PMN Number
    K891407
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER 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 NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD VACUTAINER® CPT¿ CELL PREPARATION TUBES WITH SODIUM HEPARIN HAD GLASS BREAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MATERIAL NO: 362753 BATCH NO: 0042161 IT WAS REPORTED THAT THE TUBES BROKE IN THE CENTRIFUGE. WE OPEN THE CENTRIFUGE AFTER THE FIRST CPT SPIN, TO FIND BOTH CPT'S BROKEN. THE CENTRIFUGE WAS LOADED PROPERLY AND THE LABORATORY STAFF FOLLOWED THE APPROPRIATE PROCEDURES. THE CENTRIFUGE HAD ITS LAST PREVENTATIVE MAINTENANCE ON (B)(6) 2020 AND THERE WERE NO ISSUES IDENTIFIED BY THE SERVICE ENGINEER."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 BD VACUTAINER¿ CPT" CELL PREPARATION TUBES WITH SODIUM HEPARIN HAD GLASS BREAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "MATERIAL NO: 362753 BATCH NO: 0042161. IT WAS REPORTED THAT THE TUBES BROKE IN THE CENTRIFUGE. WE OPEN THE CENTRIFUGE AFTER THE FIRST CPT SPIN, TO FIND BOTH CPT'S BROKEN. THE CENTRIFUGE WAS LOADED PROPERLY AND THE LABORATORY STAFF FOLLOWED THE APPROPRIATE PROCEDURES. THE CENTRIFUGE HAD ITS LAST PREVENTATIVE MAINTENANCE ON 11-20-2020 AND THERE WERE NO ISSUES IDENTIFIED BY THE SERVICE ENGINEER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37149 BD VACUTAINER CPT CELL PREPARATION TUBE WITH SODIUM HEPARIN BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 362753 0042161 50382903627535

    Patients

    Seq Age Sex Outcome Treatment
    1