BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SST¿

    MDR report key: 20981295 · Received December 19, 2024

    Report

    Report Number
    1024879-2024-01304
    Event Type
    Malfunction
    Date Received
    December 19, 2024
    Date of Event
    December 2, 2024
    Report Date
    February 12, 2025
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    PMA / PMN Number
    BK050036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. BD CONDUCTED VISUAL INSPECTIONS ON 30 RETAINED SAMPLES FROM LOT# 4163214 AND ANOTHER 30 RETAINED SAMPLES FROM LOT# 4163215. ALL 60 SAMPLES PASSED THE INSPECTION WITH NO FAILURES REPORTED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOTS, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THIS COMPLAINT HAS NOT BEEN CONFIRMED FOR THE LOTS 4163214 AND 4163215, FOR THE INDICATED FAILURE MODE: STOPPER COCKED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D4. MEDICAL DEVICE LOT #: 4163215 D4. MEDICAL DEVICE EXPIRATION DATE: 31-MAY-2025 D4. UNIQUE IDENTIFIER (UDI) #: (B)(4). H4. DEVICE MANUFACTURE DATE: 11-JUN-2024 E1. INITIAL REPORTER PHONE #: (B)(6) E1. INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL THERE WERE MULTIPLE 510K NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL 510K IS AS FOLLOWS: G4. PMA / 510(K)#: K230855. 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 WHILE USING BD VACUTAINER® SST¿ THAT AN UNSPECIFIED NUMBER OF TUBES FAILED TO HAVE THE CLOSURE REMOVED BY THE AUTOMATION LINE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD VACUTAINER® SST¿ THAT AN UNSPECIFIED NUMBER OF TUBES FAILED TO HAVE THE CLOSURE REMOVED BY THE AUTOMATION LINE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1949352 BD VACUTAINER® SST¿ BLOOD SPECIMEN COLLECTION DEVICE JKA BECTON, DICKINSON & CO., (BD) 4163215

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown