BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE

    MDR report key: 8597127 · Received May 9, 2019

    Report

    Report Number
    1917413-2019-01455
    Event Type
    Malfunction
    Date Received
    May 9, 2019
    Date of Event
    April 16, 2019
    Report Date
    July 31, 2019
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903627610
    PMA / PMN Number
    K911731
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: INVESTIGATION SUMMARY: 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. BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH CAPA# (B)(4). THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES OF THIS ISSUE ARE IDENTIFIED. INVESTIGATION CONCLUSION: AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. HOWEVER, FURTHER INVESTIGATION HAS BEEN INITIATED THROUGH CAPA#1092363. THE INVESTIGATION IS STILL ON-GOING AND IMPROVEMENTS WILL BE MADE AS THE POTENTIAL CAUSES ARE IDENTIFIED. ROOT CAUSE DESCRIPTION: ALTHOUGH NO SAMPLES OR PHOTOS WERE AVAILABLE FOR EVALUATION, BD HAS INITIATED FURTHER INVESTIGATION THROUGH CAPA# (B)(4) TO IDENTIFY THE POTENTIAL ROOT CAUSE(S). RATIONALE: BASED ON AN ASSESSMENT OF SEVERITY AND FREQUENCY, IT WAS DETERMINED THAT A CAPA IS REQUIRED AT THIS TIME IN ORDER TO DETERMINE THE ROOT CAUSE ASSOCIATED WITH THIS ISSUE AND IMPLEMENT CORRECTIVE ACTIONS. THE INVESTIGATION IS CURRENTLY ON-GOING AND FURTHER IMPROVEMENTS WILL BE MADE AS THE POTENTIAL ROOT CAUSE(S) ARE IDENTIFIED. H3 OTHER TEXT: SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ERRONEOUS RESULTS OCCURRED WITH A BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "PBMC CELLS YIELD PER EACH SAMPLE HANDLING WERE ABOUT 0.5 MILLION PER ML OF WHOLE BLOOD COLLECTED, WHICH WAS FAR LESS THAN THE EXPECTED RANGE." ¿WE ARE IDENTIFYING THAT AT CENTRIFUGATION AFTER BLOOD SAMPLE COLLECTION, THE MONONUCLEAR CELLS LAYER IS THINNER THAT WE OBSERVED PREVIOUSLY AT ANOTHER PBMC ISOLATION STUDY USING CPT TUBES. ALSO AFTER WASH BY DPBS AND OTHER WASH MEDIUM, CELL PELLETS SEEM TO BE LESS. PBMC CELLS YIELD PER EACH SAMPLE HANDLING WERE ABOUT 0.5 MILLION PER ML OF WHOLE BLOOD COLLECTED, WHICH WAS FAR LESS THAN THE EXPECTED RANGE.NOW WE ARE SUSPECTING THE QUALITY OF CPT TUBES AND THE LOTS USED ARE LISTED BELOW:8ML CPT TUBE BD CAT: 362761.LOT: 8243905 - USED DURING JAN-MAR2019 ((B)(4) UNITS).

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ERRONEOUS RESULTS OCCURRED WITH A BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "PBMC CELLS YIELD PER EACH SAMPLE HANDLING WERE ABOUT 0.5 MILLION PER ML OF WHOLE BLOOD COLLECTED, WHICH WAS FAR LESS THAN THE EXPECTED RANGE." ''WE ARE IDENTIFYING THAT AT CENTRIFUGATION AFTER BLOOD SAMPLE COLLECTION, THE MONONUCLEAR CELLS LAYER IS THINNER THAT WE OBSERVED PREVIOUSLY AT ANOTHER PBMC ISOLATION STUDY USING CPT TUBES. ALSO AFTER WASH BY DPBS AND OTHER WASH MEDIUM, CELL PELLETS SEEM TO BE LESS. PBMC CELLS YIELD PER EACH SAMPLE HANDLING WERE ABOUT 0.5 MILLION PER ML OF WHOLE BLOOD COLLECTED, WHICH WAS FAR LESS THAN THE EXPECTED RANGE. NOW WE ARE SUSPECTING THE QUALITY OF CPT TUBES AND THE LOTS USED ARE LISTED BELOW 8 ML CPT TUBE BD CAT: 362761. LOT: 8243905 - USED DURING (B)(6) - (B)(6) 2019 (60UNITS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    387516 BD VACUTAINER® CPT¿ CELL PREPARATION TUBE WITH SODIUM CITRATE BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 8243905 50382903627610

    Patients

    Seq Age Sex Outcome Treatment
    1 Other