BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E

    MDR report key: 8946194 · Received August 29, 2019

    Report

    Report Number
    1917413-2019-02002
    Event Type
    Malfunction
    Date Received
    August 29, 2019
    Date of Event
    August 5, 2019
    Report Date
    November 25, 2019
    Manufacturer
    BECTON, DICKINSON & CO. (BROKEN BOW)
    Product Code
    JKA
    UDI-DI
    50382903627887
    PMA / PMN Number
    K972075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR POOR SERUM/PLASMA WITH THE INCIDENT LOT WAS NOT OBSERVED. THE CUSTOMER PROVIDED PHOTOS INDICATE FLOCCULATE MATERIAL PRESENT. STORAGE CONDITIONS, NAMELY REFRIGERATION IN MOST CASES WILL CAUSE THE FORMATION OF FLOCCULATE (PRECIPITATED PLASMA PROTEINS) MATERIAL. IT IS STRONGLY RECOMMENDED THAT SAMPLES BE ALLOWED TO COME TO AMBIENT TEMPERATURE TO MITIGATE FLOCCULATE FORMATION PRIOR TO ANALYSIS. WHEN CONSIDERING USE OF MULTIPLE FREEZE/THAW CYCLES, USERS SHOULD VALIDATE THEIR OWN FREEZE/THAW PROTOCOL FOR BD PPT¿ TUBES. IN ADDITION, CONSULT ASSAY MANUFACTURER FOR RECOMMENDED TRANSPORT AND SAMPLE STORAGE REQUIREMENTS. APPROPRIATE CENTRIFUGATION TIME AND SPEED MUST BE UTILIZED ACCORDING TO INSTRUCTIONS FOR USE FOR AN INDIVIDUAL TUBE TYPE. THE CUSTOMER SAMPLES WERE EVALUATED AND NO ISSUES WERE OBSERVED. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E THERE WAS FOREIGN MATTER OF A WHITE NEAR-TRANSPARENT SUSPENSION AFTER CENTRIFUGATION. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: DURING USE THIS BATCH, THE CUSTOMER COMPLAINED THAT THE PLASMA HAD WHITE NEAR-TRANSPARENT SUSPENSION AFTER CENTRIFUGATION.

    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 DURING USE OF THE BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E THERE WAS FOREIGN MATTER OF A WHITE NEAR-TRANSPARENT SUSPENSION AFTER CENTRIFUGATION. FOREIGN COMPLAINT THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: DURING USE THIS BATCH, THE CUSTOMER COMPLAINED THAT THE PLASMA HAD WHITE NEAR-TRANSPARENT SUSPENSION AFTER CENTRIFUGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738295 BD VACUTAINER® PPT¿ PLASMA PREPARATION TUBE K2E BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO. (BROKEN BOW) 8345901 50382903627887

    Patients

    Seq Age Sex Outcome Treatment
    1 Other