BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECONOMY SOFT TISSUE BIOPSY TRAY

    MDR report key: 22691623 · Received August 1, 2025

    Report

    Report Number
    1625685-2025-00077
    Event Type
    Injury
    Date Received
    August 1, 2025
    Date of Event
    July 8, 2025
    Report Date
    November 13, 2025
    Manufacturer
    CAREFUSION, INC
    Product Code
    FSH
    UDI-DI
    10885403108563
    PMA / PMN Number
    K813338
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: THERE WERE NO PHOTOS PROVIDED FOR REVIEW, AND THE PHYSICAL SAMPLE WAS NOT RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED, AND THE ROOT CAUSE COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD DHR WAS REVIEWED, AND NO DEVIATIONS/ISSUES WERE IDENTIFIED OR ASSOCIATED WITH THE REPORTED EVENT REGARDING PRODUCT MATERIALS OR DURING MANUFACTURING, PACKAGING OR QC INSPECTION PROCESS. ALL NECESSARY INSPECTIONS WERE PERFORMED THROUGHOUT ALL MANUFACTURING, PACKAGING AND INSPECTION ACTIVITIES AND FOR RAW MATERIAL UTILIZED IN THE MANUFACTURE OF THIS LOT. THE LOT MET ALL RELEASE CRITERIA. PRODUCT UNDERGOES INSPECTIONS DURING MANUFACTURING, NO ISSUES RELATED TO THE REPORTED INCIDENT WERE IDENTIFIED, ALL PROCEDURAL AND FUNCTIONAL REQUIREMENTS FOR PRODUCT RELEASE HAVE BEEN MET. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITIONS WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR THE IDENTIFICATION OF EMERGING TRENDS. D3 (MEDICAL DEVICE MANUFACTURER), G1 (MANUFACTURING LOCATION), G3 (DATE RECEIVED BY MANUFACTURER), G4 (IS COMBINATION PRODUCT?), G6 TYPE OR REPORT - FOLLOW UP# 1), H2 (CORRECTION AND ADDITIONAL INFORMATION), H6 (ANNEX G ¿ COMPONENT CODE), ANNEX B (TYPE OF INVESTIGATION), ANNEX C (INVESTIGATION FINDINGS), ANNEX D (INVESTIGATION CONCLUSIONS). INITIAL MDR MFR REPORT # 1625685-2025-00077, SITE LEGAL NAME (FDA) REPORTED, CAREFUSION 2200, INC. - MANNFORD, OK / 74044; SITE REGISTRATION NUMBER (FDA) 1625685. CORRECT SITE LEGAL NAME (FDA) IS, VERNON HILLS; SITE REGISTRATION NUMBER (FDA) 1423507. SECTION A THROUGH F ¿ THE INFORMATION PROVIDE BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Additional Manufacturer Narrative · 0

    H11: THE LOT NUMBER WAS PROVIDED, SO A DEVICE HISTORY RECORD REVIEW IS CURRENTLY UNDERWAY. THE INVESTIGATION IS CURRENTLY UNDERWAY. H3 (DEVICE EVAL BY MANUFACTURER) A DEVICE HAS NOT BEEN RETURNED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. SECTION A THROUGH F ¿ THE INFORMATION PROVIDE BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AS THE HEALTH CARE PROVIDER (HCP) WENT TO RE-CAP THE SCALPEL OBTAINED FROM THE ECONOMY SOFT TISSUE BIOPSY TRAY, THE HCP EXPERIENCED A FINGER CUT; THEREFORE, THE HCP APPLIED A BANDAGE, AND THE ISSUE WAS CONSIDERED RESOLVED AS NO FURTHER CARE WAS NECESSARY NOR WAS IT REQUESTED BY THE HCP. THE PATIENT REPORTEDLY DID NOT HAVE ANY INFECTIOUS DISEASES AND WAS TREATED WITHOUT ANY DIFFICULTIES AND NO OTHER WORKFLOW INTERRUPTIONS HAPPENED AFTER THE INCIDENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AS THE HEALTH CARE PROVIDER (HCP) WENT TO RE-CAP THE SCALPEL OBTAINED FROM THE ECONOMY SOFT TISSUE BIOPSY TRAY, THE HCP EXPERIENCED A FINGER CUT; THEREFORE, THE HCP APPLIED A BANDAGE, AND THE ISSUE WAS CONSIDERED RESOLVED AS NO FURTHER CARE WAS NECESSARY NOR WAS IT REQUESTED BY THE HCP. THE PATIENT REPORTEDLY DID NOT HAVE ANY INFECTIOUS DISEASES AND WAS TREATED WITHOUT ANY DIFFICULTIES AND NO OTHER WORKFLOW INTERRUPTIONS HAPPENED AFTER THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920372 ECONOMY SOFT TISSUE BIOPSY TRAY TRAY, SURGICAL, NEEDLE FSH CAREFUSION, INC REKQ1420 10885403108563

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other