BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE SST PLH 13X75 3.5 PLBL GOLD

    MDR report key: 15402790 · Received September 12, 2022

    Report

    Report Number
    3003916417-2022-00184
    Event Type
    Malfunction
    Date Received
    September 12, 2022
    Date of Event
    August 9, 2022
    Report Date
    September 19, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: . MEDICAL DEVICE LOT #: 2120756, MEDICAL DEVICE EXPIRATION DATE: 2023-04-30. DEVICE MANUFACTURE DATE: 2022-06-02. MEDICAL DEVICE LOT #: 2120758, MEDICAL DEVICE EXPIRATION DATE: 2023-04-30. DEVICE MANUFACTURE DATE: 2022-06-02.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR INVESTIGATION. THEREFORE, TWO-HUNDRED (200)RETENTION SAMPLES FROM BD INVENTORY WERE EVALUATED BY VISUAL EXAMINATION AND NO ISSUES WERE OBSERVED RELATING TO STOPPER POP-OFF 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. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING TUBE SST PLH 13X75 3.5 PLBL GOLD BR THE CAPS RUPTURE AND SAMPLE SPILLS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBES HAVE BEEN PRESENTING DEFECT THAT CAUSES THE CAPS RUPTURE, AND SAMPLE SPILL AT THE MOMENT OF TRANSPORTATION AND HANDLING.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING TUBE SST PLH 13X75 3.5 PLBL GOLD BR THE CAPS RUPTURE AND SAMPLE SPILLS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TUBES HAVE BEEN PRESENTING DEFECT THAT CAUSES THE CAPS RUPTURE, AND SAMPLE SPILL AT THE MOMENT OF TRANSPORTATION AND HANDLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1807103 TUBE SST PLH 13X75 3.5 PLBL GOLD BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON IND. CIRURGICAS LTDA SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown