BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER K2 EDTA 5.4MG

    MDR report key: 10865151 · Received November 18, 2020

    Report

    Report Number
    3006948883-2020-00793
    Event Type
    Malfunction
    Date Received
    November 18, 2020
    Date of Event
    October 24, 2020
    Report Date
    January 14, 2021
    Manufacturer
    BD (SUZHOU)
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: MANUFACTURE RECORDS HAVE BEEN REVIEWED AND NO ABNORMAL WAS FOUND. DHR OF LOT 0142785 WAS REVIEWED AND NO QN FOUND. RETAINED SAMPLES WERE TESTED ON DRAW VOLUME, ALL RESULT MEET THE PRODUCT SPECIFICATION. BASE ON INVESTIGATION A CERTAIN CAUSE CANNOT BE CONCLUDED AT THE MOMENT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THE BD VACUTAINER® K2 EDTA 5.4MG EXPERIENCED UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRANSLATED TO ENGLISH. THE CUSTOMER STATED "WHEN USING THE TUBE, IT WAS FOUND THAT THE TUBE HAS A LOW DRAW ISSUE."

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE BD VACUTAINER® K2 EDTA 5.4MG EXPERIENCED UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRANSLATED TO ENGLISH. THE CUSTOMER STATED "WHEN USING THE TUBE, IT WAS FOUND THAT THE TUBE HAS A LOW DRAW ISSUE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1330561 BD VACUTAINER K2 EDTA 5.4MG BLOOD SPECIMEN COLLECTION DEVICE JKA BD (SUZHOU) 0142785

    Patients

    Seq Age Sex Outcome Treatment
    1