BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 17451121 · Received August 3, 2023

    Report

    Report Number
    9617032-2023-01011
    Event Type
    Malfunction
    Date Received
    August 3, 2023
    Date of Event
    July 14, 2023
    Report Date
    August 31, 2023
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E.1. INITIAL REPORTER PREFIX: (B)(6). H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD DID NOT RECEIVE SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 20 RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY FUNCTIONAL TESTING. NO ISSUES WERE OBSERVED RELATING TO UNDERFILL AS ALL SAMPLES MET SPECIFICATIONS. BASED ON A REVIEW OF DEVICE HISTORY RECORD FOR INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE UNDERFILL. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, THERE WAS UNDERFILL OF 2 TUBES. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PCN 366881 LOT NUMBER 3030799 ASPIRATE BADLY AND LESS THAN 7 ML AS IF THEY HAD LOST THE VACUUM. PATIENTS WERE INVOLVED IN THE EXECUTION OF THE VENIPUNCTURE, BUT THERE WERE NO IMPACTS ON THE OUTCOME AS THE NON-FUNCTIONING TUBE WAS REPLACED BEFORE CONCLUDING THE SAMPLING. THIS, THEREFORE, DID NOT LEAD TO NEGATIVE OUTCOMES FOR THE PATIENT OR INVALIDATE THE RESULT OF THE SAMPLE ITSELF.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES, THERE WAS UNDERFILL OF 2 TUBES. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PCN 366881 LOT NUMBER 3030799 ASPIRATE BADLY AND LESS THAN 7 ML AS IF THEY HAD LOST THE VACUUM. PATIENTS WERE INVOLVED IN THE EXECUTION OF THE VENIPUNCTURE, BUT THERE WERE NO IMPACTS ON THE OUTCOME AS THE NON-FUNCTIONING TUBE WAS REPLACED BEFORE CONCLUDING THE SAMPLING. THIS, THEREFORE, DID NOT LEAD TO NEGATIVE OUTCOMES FOR THE PATIENT OR INVALIDATE THE RESULT OF THE SAMPLE ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284599 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 3030799

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown