BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD TUBE K2EDTA PLH 13X75 3.0 PLBL LAV BR

    MDR report key: 12196921 · Received July 20, 2021

    Report

    Report Number
    3003916417-2021-00178
    Event Type
    Malfunction
    Date Received
    July 20, 2021
    Date of Event
    June 25, 2021
    Report Date
    October 4, 2021
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    JKA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL PROVIDED INFORMATION: D.4. MEDICAL DEVICE LOT #: 1051633. D.4. MEDICAL DEVICE EXPIRATION DATE: 2022-06-30. H.4. DEVICE MANUFACTURE DATE: 2021-03-23.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION. H6: INVESTIGATION SUMMARY. BD HAD NOT RECEIVED SAMPLES BUT 2 PHOTOS OF LOT 1051647 AND 1051633 FOR INVESTIGATION. PHOTOS WERE REVIEWED AND THE INDICATED FAILURE MODE OF UNDERFILL WAS NOT OBSERVED. THEREFORE, 5 RETENTION SAMPLES FROM EACH LOT WERE SELECTED FROM BD INVENTORY AND WERE EVALUATED BY DRAW TESTING AND NO ISSUES WERE OBSERVED RELATING TO UNDERFILL AS ALL SAMPLES MET SPECIFICATIONS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. BD WAS NOT ABLE TO IDENTIFIY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TREN H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD¿ TUBE K2EDTA PLH 13X75 3.0 PLBL LAV BR THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE TUBES ARE ASPIRATING A LOWER VOLUME THAN INDICATED."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD¿ TUBE K2EDTA PLH 13X75 3.0 PLBL LAV BR THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE TUBES ARE ASPIRATING A LOWER VOLUME THAN INDICATED."

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0344063 MEDICAL DEVICE EXPIRATION DATE: 2022-04-30 DEVICE MANUFACTURE DATE: 2021-02-11. MEDICAL DEVICE LOT #: 1051647 MEDICAL DEVICE EXPIRATION DATE: 2022-06-30 DEVICE MANUFACTURE DATE: 2021-03-23. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, 5 RETENTION SAMPLES FROM EACH LOT WERE SELECTED FROM BD INVENTORY AND WERE EVALUATED BY DRAW TESTING AND NO ISSUES WERE OBSERVED RELATING TO UNDERFILL AS ALL SAMPLES MET SPECIFICATIONS. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE BD¿ TUBE K2EDTA PLH 13X75 3.0 PLBL LAV BR THERE WAS UNDER-FILL OR LOW DRAW OF A TUBE WITH BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE TUBES ARE ASPIRATING A LOWER VOLUME THAN INDICATED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1096675 BD TUBE K2EDTA PLH 13X75 3.0 PLBL LAV BR BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON IND. CIRURGICAS LTDA SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1