BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SERUM BLOOD COLLECTION TUBE

    MDR report key: 13005112 · Received December 14, 2021

    Report

    Report Number
    1024879-2021-00859
    Event Type
    Malfunction
    Date Received
    December 14, 2021
    Date of Event
    November 18, 2021
    Report Date
    January 5, 2022
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    50382903666688
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. 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. THIS COMPLAINT IS UNABLE TO BE CONFIRMED. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THIS COMPLAINT WILL BE REOPENED TO ASSESS THE LEVEL OF INVESTIGATION NEEDED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED MISSING ADDITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT WHEN CENTRIFUGING THE SERUM SEPARATES INTO A GEL LIKE CONSISTENCY AND THEY HAVE TO CENTRIFUGE IT AGAIN TO COMPLETE THE FULL SEPARATION. (B)(6): ON (B)(6) 2021 17:34:31 (GMT); REFERENCE (B)(4) FOR SAME COMPLAINT ON A DIFFERENT PRODUCT NUMBER. VERBATIM, "BLOOD COLLECTION W/ CATS AND DOGS, AND WHEN THEY GO TO SEPARATE THE TUBES, THE SERUM, AND SOME IT SEPARATES INTO A GEL LIKE CONSISTENCY, AND USUALLY THE CENTRIFUGE IT AGAIN AND IT COMPLETES THE FULL SEPARATION. WONDERING HOW TO GET IT TO SEPARATE THE FIRST TIME, THEY¿VE TRIED DIFFERENT TEMPERATURES/PLACING ON ICE/ETC, ALSO TRIED INCREASING CENTRIFUGE BEADS FROM 1300 TO 3000G". EVENT DATE: UNKNOWN - HAPPENING SINCE (B)(6); MATERIAL NO: 366668; LOT NO: UNKNOWN; QTY: UNKNOWN. BASED ON THE INFORMATION PROVIDED, OUR CONCLUSION IS THAT THE DEVICE CITED MEETS OUR CRITERIA OF A COMPLAINT ¿ APPENDIX A - COMPLAINT DETERMINATION TREE ¿ ((B)(4)).

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD VACUTAINER® SERUM BLOOD COLLECTION TUBES, THE DEVICE EXPERIENCED MISSING ADDITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT WHEN CENTRIFUGING THE SERUM SEPARATES INTO A GEL LIKE CONSISTENCY AND THEY HAVE TO CENTRIFUGE IT AGAIN TO COMPLETE THE FULL SEPARATION. (B)(6): (B)(6) 2021 17:34:31 (GMT) REFERENCE (B)(4) FOR SAME COMPLAINT ON A DIFFERENT PRODUCT NUMBER. VERBATIM, "BLOOD COLLECTION W/ CATS AND DOGS, AND WHEN THEY GO TO SEPARATE THE TUBES, THE SERUM, AND SOME IT SEPARATES INTO A GEL LIKE CONSISTENCY, AND USUALLY THE CENTRIFUGE IT AGAIN AND IT COMPLETES THE FULL SEPARATION. WONDERING HOW TO GET IT TO SEPARATE THE FIRST TIME, THEY¿VE TRIED DIFFERENT TEMPERATURES/PLACING ON ICE/ETC, ALSO TRIED INCREASING CENTRIFUGE BEADS FROM 1300 TO 3000G". EVENT DATE: UNKNOWN - HAPPENING SINCE APRIL. MATERIAL NO: 366668, LOT NO: UNKNOWN, QTY: UNKNOWN. BASED ON THE INFORMATION PROVIDED, OUR CONCLUSION IS THAT THE DEVICE CITED MEETS OUR CRITERIA OF A COMPLAINT ¿ APPENDIX A - COMPLAINT DETERMINATION TREE ¿ (NASSC-RCC-007). *SEE CASE COMMENTS FOR RELATED CASE ON A DIFFERENT MATERIAL NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1894621 BD VACUTAINER® SERUM BLOOD COLLECTION TUBE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 366668 UNKNOWN 50382903666688

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown