BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE K2EDTA PLH 13X75 4.0 PLBL LAV BR

    MDR report key: 9134659 · Received September 30, 2019

    Report

    Report Number
    3003916417-2019-00483
    Event Type
    Malfunction
    Date Received
    September 30, 2019
    Date of Event
    September 11, 2019
    Report Date
    December 10, 2019
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: 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 THE EXPIRATION DATE IN THE INVOICE NOT CORRESPONDING TO THE EXPIRATION DATE IN THE LABEL WITH THE INCIDENT LOT WAS 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. IT WAS VERIFIED THAT THE DATE ON THE PRODUCT WAS CORRECT (31.10.2020), WHICH DENOTES THE LAST DAY OF THE DUE MONTH AS PER PROCEDURE REQUIREMENTS, AS FOR THE DATE IN THE INVOICE (10/26/2020) IT DOES NOT HAVE THE LAST DAY OF THE EXPIRATION MONTH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TUBE K2EDTA PLH 13X75 4.0 PLBL LAV BR HAD INCORRECT LABEL INFORMATION. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER QUESTIONS ABOUT THE EXPIRATION DATE OF THE TUBES PRODUCED BY CURITIBA, AS THE SYSTEM INFORMATION DIFFERS FROM THE PHYSICAL LABELS. THE EXPIRATION DATE IN THE INVOICE DOES NOT CORRESPONDS TO THE EXPIRATION DATE IN THE LABEL.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 9180512. MEDICAL DEVICE EXPIRATION DATE: 2020-10-26. DEVICE MANUFACTURE DATE: 2019-07-26. MEDICAL DEVICE LOT #: 9180513. MEDICAL DEVICE EXPIRATION DATE: 2020-10-26. DEVICE MANUFACTURE DATE: 2019-08-05. 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 TUBE K2EDTA PLH 13X75 4.0 PLBL LAV BR HAD INCORRECT LABEL INFORMATION. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER QUESTIONS ABOUT THE EXPIRATION DATE OF THE TUBES PRODUCED BY CURITIBA, AS THE SYSTEM INFORMATION DIFFERS FROM THE PHYSICAL LABELS. THE EXPIRATION DATE IN THE INVOICE DOES NOT CORRESPONDS TO THE EXPIRATION DATE IN THE LABEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931720 TUBE K2EDTA PLH 13X75 4.0 PLBL LAV BR BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON IND. CIRURGICAS LTDA SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other