BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST II PLUS PLASTIC SERUM TUBE 16 X 100 MM X 8.5 ML

    MDR report key: 7066593 · Received November 29, 2017

    Report

    Report Number
    9617032-2017-00256
    Event Type
    Malfunction
    Date Received
    November 29, 2017
    Date of Event
    June 1, 2015
    Report Date
    November 2, 2017
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    UDI-DI
    00382903679539
    PMA / PMN Number
    K023331
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). RESULTS: A SAMPLE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 4181323. (B)(4) RETAINED SAMPLES FROM THE SAME LOT WERE TESTED BY SIMULATED USE. (B)(4) TUBE OF THE RETAINED SAMPLES EXAMINED HAD THE PRESENCE OF GEL GLOBULES AND CONFIRMED CUSTOMERS' INDICATED FAILURE MODE. CONCLUSION: CONFIRMED COMPLAINT. BD WAS ABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE FOR ADDITIVE ISSUES BECAUSE THE DEFECT WAS EVIDENT IN THE TESTING OF THE RETAINED SAMPLES. AN 8D PROJECT IS UNDERWAY, LOOKING INTO THE OIL GEL GLOBULE FORMATION FOR POTENTIAL CAUSES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VACUTAINER® SST II PLUS PLASTIC SERUM TUBE (16 X 100 MM X 8.5 ML) WAS DEFECTIVE CAUSING GEL GLOBULES AND FIBRIN CLOTS IN SERUM, AFTER CENTRIFUGATION. NO INJURY, BLOOD EXPOSURE OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848890 BD VACUTAINER® SST II PLUS PLASTIC SERUM TUBE 16 X 100 MM X 8.5 ML BLOOD COLLECTION TUBE JKA BECTON, DICKINSON AND COMPANY (BD) 4181323 00382903679539

    Patients

    Seq Age Sex Outcome Treatment
    1 Other