BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD TUBE SST PLH 13X75 3.5 PLBL GOLD BR

    MDR report key: 15504585 · Received September 29, 2022

    Report

    Report Number
    3003916417-2022-00218
    Event Type
    Malfunction
    Date Received
    September 29, 2022
    Date of Event
    September 16, 2022
    Report Date
    November 7, 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

    H6: 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 STOPPER POP OFF. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 · 0

    IT WAS REPORTED WHEN USING THE BD TUBE SST PLH 13X75 3.5 PLBL GOLD BR THE STOPPER POPPED OUT OF THE TUBE CAUSING SPILLAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER AND TRANSLATED TO ENGLISH. THE CUSTOMER STATED: "THE 3.5 ML YELLOW CAP GEL TUBES WITH BD VACUTAINER C 100 SEPARATOR GEL FROM LOT: 2181401 ARE LOOSENING THE CAP AS SOON AS THE VACUUM COMES OUT DURING COLLECTION, CAUSING THE SPILLAGE OF THE BIOLOGICAL SAMPLE."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD TUBE SST PLH 13X75 3.5 PLBL GOLD BR THE STOPPER POPPED OUT OF THE TUBE CAUSING SPILLAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER AND TRANSLATED TO ENGLISH. THE CUSTOMER STATED: "THE 3.5 ML YELLOW CAP GEL TUBES WITH BD VACUTAINER C 100 SEPARATOR GEL FROM LOT: 2181401 ARE LOOSENING THE CAP AS SOON AS THE VACUUM COMES OUT DURING COLLECTION, CAUSING THE SPILLAGE OF THE BIOLOGICAL SAMPLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1603938 BD TUBE SST PLH 13X75 3.5 PLBL GOLD BR BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON DICKINSON IND. CIRURGICAS LTDA 2181401

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown