BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES

    MDR report key: 11784384 · Received May 6, 2021

    Report

    Report Number
    9617032-2021-00413
    Event Type
    Malfunction
    Date Received
    May 6, 2021
    Date of Event
    April 12, 2021
    Report Date
    May 18, 2021
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    50382903666435
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 2021-05-27. H6: INVESTIGATION SUMMARY: BD RECEIVED 3 SAMPLES AND 4 PHOTOS FOR INVESTIGATION. THE PHOTOS AND SAMPLES WERE REVIEWED AND THE INDICATED FAILURE MODE FOR ADDITIVE ABNORMALITY WITH THE INCIDENT LOT WAS OBSERVED. THIS IS RECOGNIZED TO BE AN AESTHETIC DEFECT WITH NO IMPACT ON THE EFFICACY OF THE TUBE. ADDITIONALLY, 100 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF ADDITIVE ABNORMALITY WAS NOT OBSERVED. BD DETERMINED THAT THE ROOT CAUSE OF THE INDICATED FAILURE MODE WAS ATTRIBUTED TO MANUFACTURING. THE ROOT CAUSE FOR THIS TYPE OF DEFECT IS THAT THE ADDITIVE SPRAY NOZZLE HAS BECOME SLIGHTLY OCCLUDED CAUSING THE SPRAY PATTERN TO BE COARSER. IN TURN THIS BECOMES SLIGHTLY YELLOW WHEN IRRADIATED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 25 BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES HAD DISCOLORED ADDITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT THE TUBE ADDITIVE WAS ABNORMAL. PER EMAIL: I RECEIVED A GENESYS CALL FROM THIS CUSTOMER. SHE WAS INQUIRING AS TO WHAT WAS THE SUBSTANCE IN THE ITEM NUMBER 366643 LOT 0132366. SHE STATED OUT OF A BOX OF 100, SHE NOTICED SEVERAL LOOKED LIKE THE IMAGES SHE PROVIDED AND WANTS TO KNOW IF THEY ARE SAFE TO USE. I EXPLAINED I WOULD TAKE THE INFO PROVIDED AND FORWARD IT TO OUR PAS TEAM TO SEE IF AN INVESTIGATION IS NECESSARY AND IF WE NEED TO RETRIEVE THE PRODUCT QUESTIONED. PLEASE LET THE CUSTOMER KNOW WHAT AND WHEN YOU CAN."

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 25 BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES HAD DISCOLORED ADDITIVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " IT WAS REPORTED THAT THE TUBE ADDITIVE WAS ABNORMAL. PER EMAIL: I RECEIVED A GENESYS CALL FROM THIS CUSTOMER,. SHE WAS INQUIRING AS TO WHAT WAS THE SUBSTANCE IN THE ITEM NUMBER 366643 LOT 0132366. SHE STATED OUT OF A BOX OF 100, SHE NOTICED SEVERAL LOOKED LIKE THE IMAGES SHE PROVIDED AND WANTS TO KNOW IF THEY ARE SAFE TO USE. I EXPLAINED I WOULD TAKE THE INFO PROVIDED AND FORWARD IT TO OUR PAS TEAM TO SEE IF AN INVESTIGATION IS NECESSARY AND IF WE NEED TO RETRIEVE THE PRODUCT QUESTIONED. PLEASE LET THE CUSTOMER KNOW WHAT AND WHEN YOU CAN. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682775 BD VACUTAINER K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 366643 0132366 50382903666435

    Patients

    Seq Age Sex Outcome Treatment
    1