BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    MDR report key: 8636146 · Received May 23, 2019

    Report

    Report Number
    9617032-2019-00616
    Event Type
    Malfunction
    Date Received
    May 23, 2019
    Date of Event
    May 6, 2019
    Report Date
    July 9, 2019
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    BK050036
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES, BUT PHOTOS WERE PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR ABNORMAL BARRIER SEPARATION WITH THE INCIDENT LOT WAS NOT OBSERVED. GEL SEPARATION IN THE PHOTO PRESENTED, MEETS THE EXPECTATIONS. 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. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER PHOTOS, THE CUSTOMER¿S INDICATED FAILURE MODE FOR ABNORMAL BARRIER SEPARATION WITH THE INCIDENT LOT WAS NOT OBSERVED. THE PHOTOS DID NOT IDENTIFY A SPECIFIC PRODUCT ISSUE. ROOT CAUSE DESCRIPTION: BASED ON THE INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES HAD ABNORMAL GEL SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DETAILS OF SPECIMEN COLLECTION NOT KNOWN. CENTRIFUGATION PROTOCOL: KUBOTA, SWING BUCKET, 3500 RPM FOR 10 MINUTES. OTHER INFORMATION: HIV TEST REQUESTED. HAS REQUESTED FOR A REDRAW. SAMPLE ARRIVED ON 10TH MAY 2019 AT 3+ PM DETAILS OF SPECIMEN COLLECTION AND COLLECTION TIME NOT KNOWN SPECIMEN WAS DRAWN IN SSTII TUBE (LOT NO.8295722, EXP 2020-04) CENTRIFUGED IN REFRIGERATED KUBOTA SWING BUCKET, 3500 RPM FOR 10 MINUTES AT 18C. NO PROBLEM WITH GEL SEPARATION.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: 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 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES HAD ABNORMAL GEL SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DETAILS OF SPECIMEN COLLECTION NOT KNOWN. CENTRIFUGATION PROTOCOL: KUBOTA, SWING BUCKET, 3500 RPM FOR 10 MINUTES. OTHER INFORMATION: HIV TEST REQUESTED. HAS REQUESTED FOR A REDRAW. SAMPLE ARRIVED ON (B)(6) 2019 AT 3+ PM. DETAILS OF SPECIMEN COLLECTION AND COLLECTION TIME NOT KNOWN. SPECIMEN WAS DRAWN IN SSTII TUBE (LOT NO.8295722, EXP 2020-04). CENTRIFUGED IN REFRIGERATED KUBOTA SWING BUCKET, 3500 RPM FOR 10 MINUTES AT 18C. NO PROBLEM WITH GEL SEPARATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428277 BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 8186964

    Patients

    Seq Age Sex Outcome Treatment
    1 Other