BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES

    MDR report key: 21595016 · Received March 13, 2025

    Report

    Report Number
    3003916417-2025-00023
    Event Type
    Malfunction
    Date Received
    March 13, 2025
    Date of Event
    February 13, 2025
    Report Date
    July 11, 2025
    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
    AR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. D4. UNIQUE IDENTIFIER (UDI) #: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. LOT NUMBER WAS NOT REPORTED; HOWEVER, POTENTIAL LOT NUMBERS WERE PROVIDED. THE INFORMATION FOR THESE NUMBERS ARE AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 4150237. D4. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2025. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). H4. DEVICE MANUFACTURE DATE: 04-JUL-2024. D4. MEDICAL DEVICE LOT #: 4207154. D4. MEDICAL DEVICE EXPIRATION DATE: 31-JUL-2025. D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). H4. DEVICE MANUFACTURE DATE: 29-AUG-2024. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY BD DID NOT RECEIVE ANY SAMPLES; HOWEVER, A PHOTO WAS SENT FOR EVALUATION. BD WAS NOT ABLE TO CONFIRM THE REPORTED INCIDENT BASED ON THE IMAGE PROVIDED. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF FEBRUARY 2025. AT THIS TIME, FURTHER TESTING IS NOT INDICATED. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THE REPORTED ISSUE; THEREFORE, A REVIEW OF THE DEVICE HISTORY COULD NOT BE PERFORMED. AS A RESULT, THIS COMPLAINT COULD NOT BE CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND THE REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND ASSESSED. THE INFORMATION WILL BE CAPTURED IN TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA TO IDENTIFY EMERGING TRENDS. BD QUALITY WILL CONTINUE TO MONITOR SAMPLE QUALITY COMPLAINTS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES CONTAIN OIL GEL GLOBULES. THE OIL GEL GLOBULES ARE CAUSING A BUILDUP ON THE ELECTRODE OF THEIR INSTRUMENT. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES, AN UNSPECIFIED NUMBER OF TUBES CONTAIN OIL GEL GLOBULES. THE OIL GEL GLOBULES ARE CAUSING A BUILDUP ON THE ELECTRODE OF THEIR INSTRUMENT. THERE WAS NO HEALTH IMPACT OR CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1700783 BD VACUTAINER® SST¿ BLOOD COLLECTION TUBES TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION JKA BECTON DICKINSON IND. CIRURGICAS LTDA UNKNOWN 30382903600602

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown