BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 20630132 · Received November 7, 2024

    Report

    Report Number
    3003916417-2024-00256
    Event Type
    Malfunction
    Date Received
    November 7, 2024
    Date of Event
    October 9, 2024
    Report Date
    December 27, 2024
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    JKA
    UDI-DI
    30382903600602
    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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B.5 DESCRIBE EVENT OR PROBLEM: "LOT 4031209, 96 TUBES." THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVALUATION: YES. H.3 DEVICE EVAL BY MANUFACTURER? YES. D9: RETURNED TO MANUFACTURER ON: 11-DEC-2024. INVESTIGATION SUMMARY: BD RECEIVED NINETY-THREE (93) SAMPLES AND ONE (1) PHOTO FROM BATCH 4031209 FOR INVESTIGATION. THE SAMPLES AND PHOTO WERE REVIEWED AND THE INDICATED FAILURE MODE FOR GEL AIR BUBBLES WAS OBSERVED. ADDITIONALLY, TWO HUNDRED (200) RETENTION SAMPLES FROM BD INVENTORY (BATCHES 3179643, 3303920, 3059232, 3273763, AND 3177823) WERE EVALUATED BY VISUAL EXAMINATION AND THE ISSUE OF GEL AIR BUBBLES WAS OBSERVED IN ALL BATCHES. 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 HAS BEEN CONFIRMED FOR THE INDICATED FAILURE MODE OF GEL AIR BUBBLES. BD WAS NOT ABLE TO IDENTIFY 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 TRENDS.

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH ADDITIONAL LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 3179643. D4. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2024. H4. DEVICE MANUFACTURE DATE: 12-JUL-2023. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). D4. MEDICAL DEVICE LOT #: 3303920. D4. MEDICAL DEVICE EXPIRATION DATE: 31-OCT-2024. H4. DEVICE MANUFACTURE DATE: 27-NOV-2023. D4. UNIQUE IDENTIFIER (UDI) #:(B)(4). D4. MEDICAL DEVICE LOT #:3273763. D4. MEDICAL DEVICE EXPIRATION DATE: 30-SEP-2024. H4. DEVICE MANUFACTURE DATE: 17-OCT-2023. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). D4. MEDICAL DEVICE LOT #:3059232. D4. MEDICAL DEVICE EXPIRATION DATE: 29-FEB-2024. H4. DEVICE MANUFACTURE DATE: 12-APR-2023. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). D4. MEDICAL DEVICE LOT #: 4031209. D4. MEDICAL DEVICE EXPIRATION DATE: 31-JAN-2025. H4. DEVICE MANUFACTURE DATE: 06-MAR-2024. D4. UNIQUE IDENTIFIER (UDI) # (B)(4). E.1: INITIAL REPORTER PHONE #: (B)(6). 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 · 0

    IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, GEL AIR BUBBLES WERE OBSERVED AS FOLLOWS:LOT 3179643, 332 TUBESLOT 3303920, 97 TUBES LOT 3273763, 84 TUBES LOT 3059232, 29 TUBESLOT 4031209, 96 TUBESLOT 3177823 , 91 TUBESTHERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED PRIOR TO USE OF BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, GEL AIR BUBBLES WERE OBSERVED AS FOLLOWS: LOT 3179643, 332 TUBES. LOT 3303920, 97 TUBES. LOT 3273763, 84 TUBES. LOT 3059232, 29 TUBES. LOT 4031209, 60 TUBES. LOT 3177823 , 91 TUBES. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1796897 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON DICKINSON IND. CIRURGICAS LTDA 3177823 30382903600602

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown