BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE K2EDTA PLH 13X75 2.0 PLBL LAV BR

    MDR report key: 10920697 · Received November 30, 2020

    Report

    Report Number
    2243072-2020-01955
    Event Type
    Malfunction
    Date Received
    November 30, 2020
    Date of Event
    November 9, 2020
    Report Date
    January 20, 2021
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    JKA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THE TUBE K2EDTA PLH 13X75 2.0 PLBL LAV BR HAD THE INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRANSLATED TO ENGLISH. THE CUSTOMER STATED: CUSTOMER RECEIVED "1 BOX CLOSED WITH 10 PACKAGES. THE BOX WAS IDENTIFIED AS EDTA 2 ML, HOWEVER INSIDE THERE WERE EDTA 4ML. BOX CLOSED BY MANUFACTURER. BOARDING BOX IDENTIFIED AS EDTA 2ML (SKU 360055 AND LOT 0090424). INSIDE, THE TUBES WERE EDTA 4ML (SKU 360057 AND LOT 0080546)." D.3. MEDICAL DEVICE MANUFACTURER: BECTON DICKINSON IND. CIRURGICAS LTDA D.4 MEDICAL DEVICE CATALOG #: 360055 H.4. UNIQUE IDENTIFIER (UDI) #: (B)(4)D.4. MEDICAL DEVICE LOT #: 0090424 D.4. MEDICAL DEVICE EXPIRATION DATE: 2021-06-30 G.2 MANUFACTURING LOCATION: BECTON DICKINSON IND. CIRURGICAS LTDA G.7. TYPE OF REPORT: FOLLOW UP #2 H.2. TYPE OF FOLLOW UP: ADDITIONAL INFORMATION H.4. DEVICE MANUFACTURE DATE: 2020-04-16.

    Description of Event or Problem · 0

    IT WAS REPORTED THE UNSPECIFIED VACUTAINER BLOOD COLLECTION TUBE HAD THE INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRANSLATED TO ENGLISH. THE CUSTOMER STATED: CUSTOMER RECEIVED "1 BOX CLOSED WITH 10 PACKAGES. THE BOX WAS IDENTIFIED AS EDTA 2 ML, HOWEVER INSIDE THERE WERE EDTA 4ML. PS: BOX CLOSED BY MANUFACTURER.".

    Description of Event or Problem · 0

    IT WAS REPORTED THE TUBE K2EDTA PLH 13X75 2.0 PLBL LAV BR HAD THE INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRANSLATED TO ENGLISH. THE CUSTOMER STATED: CUSTOMER RECEIVED "1 BOX CLOSED WITH 10 PACKAGES. THE BOX WAS IDENTIFIED AS EDTA 2 ML, HOWEVER INSIDE THERE WERE EDTA 4ML. BOX CLOSED BY MANUFACTURER. BOARDING BOX IDENTIFIED AS EDTA 2ML (SKU 360055 AND LOT 0090424). INSIDE, THE TUBES WERE EDTA 4ML (SKU 360057 AND LOT 0080546)."

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: (B)(4). DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE UNSPECIFIED VACUTAINER BLOOD COLLECTION TUBE HAD THE INCORRECT LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TRANSLATED TO ENGLISH. THE CUSTOMER STATED: CUSTOMER RECEIVED "1 BOX CLOSED WITH 10 PACKAGES. THE BOX WAS IDENTIFIED AS EDTA 2 ML, HOWEVER INSIDE THERE WERE EDTA 4ML. PS: BOX CLOSED BY MANUFACTURER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1387809 TUBE K2EDTA PLH 13X75 2.0 PLBL LAV BR BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON IND. CIRURGICAS LTDA 0090424

    Patients

    Seq Age Sex Outcome Treatment
    1