BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBE SST PLH 13X100 5.0 PLBL GOLD BR

    MDR report key: 12037053 · Received June 21, 2021

    Report

    Report Number
    3003916417-2021-00151
    Event Type
    Malfunction
    Date Received
    June 21, 2021
    Date of Event
    May 21, 2021
    Report Date
    June 23, 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

    H.6. INVESTIGATION: 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. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE TUBE SST PLH 13X100 5.0 PLBL GOLD BR THE STOPPER POPS OUT OF THE TUBE. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THERE WERE TWO INCIDENTS WHERE THE TUBES HAVE OPENED SPONTANEOUSLY DURING TRANSPORTATION. THE DRAW WAS PERFORMED USING THE VACUUM (CLOSED SAMPLE COLLECTION), AND THEREFORE THE HANDLING OF TUBES BY THE LAB WAS ONLY WITH THE TUBES CLOSED."

    Additional Manufacturer Narrative · 1

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1051687. MEDICAL DEVICE LOT #: 1051693. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE TUBE SST PLH 13X100 5.0 PLBL GOLD BR THE STOPPER POPS OUT OF THE TUBE. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THERE WERE TWO INCIDENTS WHERE THE TUBES HAVE OPENED SPONTANEOUSLY DURING TRANSPORTATION. THE DRAW WAS PERFORMED USING THE VACUUM (CLOSED SAMPLE COLLECTION), AND THEREFORE THE HANDLING OF TUBES BY THE LAB WAS ONLY WITH THE TUBES CLOSED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    929491 TUBE SST PLH 13X100 5.0 PLBL GOLD BR BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON IND. CIRURGICAS LTDA 1051693

    Patients

    Seq Age Sex Outcome Treatment
    1