BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

    MDR report key: 22185688 · Received June 11, 2025

    Report

    Report Number
    1024879-2025-00833
    Event Type
    Malfunction
    Date Received
    June 11, 2025
    Date of Event
    May 15, 2025
    Report Date
    November 14, 2025
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FPA
    UDI-DI
    30382903673262
    PMA / PMN Number
    K220212
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: 02-JUN-2025. INVESTIGATION SUMMARY: BD RECEIVED SEVEN SAMPLES AND 11 PHOTOS FOR INVESTIGATION RELATED TO LOT NUMBERS 4030227. EVALUATION OF THE PHOTOS SHOWS SAMPLES EXHIBITED BOTH REPORTED ISSUES. UPON VISUAL INSPECTION, ONE OF THE RETURNED SAMPLES FAILED DUE TO SEVERED TUBING. ADDITIONALLY, 100 RETAINED SAMPLES FROM THE SAME LOTS WERE EVALUATED THROUGH VISUAL INSPECTIONS FOR SEVERED TUBING AND PREACTIVATION. ALL RETAINED SAMPLES PASSED THE INSPECTIONS WITH NO DEFECTS OBSERVED. 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 BEEN CONFIRMED FOR THE LOT 4030227, FOR THE INDICATED FAILURE MODES: PREACTIVATION AND SEVERED. 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

    E1: INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. D.2B MEDICAL DEVICE TYPE: ONE ADDITIONAL CODE APPLIES; JKA. 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 THAT BEFORE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE NEEDLE RETRACTION BUTTON FOUND TO BE PRESSED FROM THE START AND THE TUBING WAS CUT IN THE MIDDLE OF ONE DEVICE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USING BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET, THE NEEDLE RETRACTION BUTTON FOUND TO BE PRESSED FROM THE START AND THE TUBING WAS CUT IN THE MIDDLE OF ONE DEVICE. THERE WAS NO HEALTH IMPACT OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91374 BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET INTRAVASCULAR ADMINISTRATION SET FPA BECTON, DICKINSON & CO., (BD) 4030227 30382903673262

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown