BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOFLO MIDLINE 4F SL-20CM MAX STERILE BARRIER NURSING KIT

    MDR report key: 23653002 · Received November 25, 2025

    Report

    Report Number
    3030714660-2025-00010
    Event Type
    Malfunction
    Date Received
    November 25, 2025
    Date of Event
    October 29, 2025
    Report Date
    November 21, 2025
    Manufacturer
    SPECTRUM VASCULAR
    Product Code
    FOZ
    UDI-DI
    H965464701
    PMA / PMN Number
    K161866
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION OF THE GUIDEWIRE TIP DETACHED CANNOT BE CONFIRMED SINCE NO COMPLAINT SAMPLE WAS RETURNED. WITHOUT RECEIVING PRODUCT FOR EVALUATION, WE ARE UNABLE TO DEFINITIVELY DETERMINE A ROOT CAUSE FOR THIS INCIDENT. DHR REVIEW OF THE PACKAGING/ACCESSORY LOTS REVEALED NO QUALITY RELATED ISSUES OR MANUFACTURING DEFICIENCIES AT THE TIME OF MANUFACTURE. LABELING REVIEW: DFU ITEM NUMBER {14600281-01 REV 02} IS PROVIDED WITH THE DEVICE AND CONTAINS THE FOLLOWING STATEMENTS: "(PAGE 4) WARNING CONTENTS SUPPLIED STERILE USING AN ETHYLENE OXIDE (EO) PROCESS. DO NOT USE IF STERILE BARRIER IS DAMAGED. IF DAMAGE IS FOUND, CALL YOURSALES REPRESENTATIVE. INSPECT PRIOR TO USE TO VERIFY THAT NO DAMAGE HAS OCCURRED IN SHIPPING. FOR SINGLE PATIENT USE ONLY. DO NOT REUSE, REPROCESS OR RESTERILIZE. REUSE, REPROCESSING OR RESTERILIZATION MAY COMPROMISE THE STRUCTURAL INTEGRITY OF THE DEVICE AND/OR LEAD TO DEVICE FAILURE WHICH, IN TURN, MAY RESULT IN PATIENT INJURY, ILLNESS OR DEATH. REUSE, REPROCESSING OR RESTERILIZATION MAY ALSO CREATE A RISK OF CONTAMINATION OF THE DEVICE AND/OR CAUSE PATIENT INFECTION OR CROSS-INFECTION, INCLUDING, BUT NOT LIMITED TO, THE TRANSMISSION OF INFECTIOUS DISEASE(S) FROM ONE PATIENT TO ANOTHER. CONTAMINATION OF THE DEVICE MAY LEAD TO INJURY, ILLNESS OR DEATH OF THE PATIENT. AFTER USE, DISPOSE OF PRODUCT AND PACKAGING IN ACCORDANCE WITH HOSPITAL, ADMINISTRATIVE AND/OR LOCAL GOVERNMENT POLICY. (PAGE 5) PRECAUTIONS REFER TO PROCEDURAL STEPS FOR ADDITIONAL PRECAUTIONS. DO NOT ADVANCE A GUIDEWIRE PAST THE LEVEL OF THE AXILLA. NEVER USE FORCE TO REMOVE THE STYLET. RESISTANCE CAN DAMAGE THE CATHETER. IF RESISTANCE OR BUNCHING OF THE CATHETER IS OBSERVED, STOP STYLET WITHDRAWAL AND ALLOW THE CATHETER TO RETURN TO NORMAL SHAPE. WITHDRAW BOTH THE CATHETER AND STYLET TOGETHER APPROXIMATELY 2 CM AND RE-ATTEMPT STYLET REMOVAL. REPEAT THIS PROCEDURE UNTIL THE STYLET IS EASILY REMOVED. ONCE THE STYLET IS OUT, ADVANCE THE CATHETER INTO DESIRED POSITION (ZERO MARK). IF GUIDEWIRE MUST BE WITHDRAWN, REMOVE THE NEEDLE AND GUIDEWIRE AS A SINGLE UNIT. (PAGE 6-7) INSTRUCTIONS FOR USE CATHETER INSERTION DIRECTIONS PATIENT PREPARATION 1. IF PLACING CATHETER AT PATIENT BEDSIDE, APPLY TOURNIQUET TO UPPER ARM. SELECT A VEIN BASED ON PATIENT ASSESSMENT. COMMON VEINS USED FOR INSERTION INCLUDE THE BASILIC, BRACHIALS AND CEPHALIC. RELEASE TOURNIQUET. 2. PREPARE STERILE FIELD AND SUPPLIES. 3. PREPARE INSERTION SITE AND SURROUNDING AREA WITH AN ACCEPTABLE TOPICAL ANTIMICROBIAL CLEANSING AGENT ACCORDING TO INSTITUTIONAL PROTOCOL, POLICIES AND PROCEDURES. VENOUS ACCESS 4. ACCESS VEIN USING THE APPROPRIATE METHOD BELOW. USING GUIDEWIRE A. INSERT INTRODUCER NEEDLE, BEVEL UP, INTO SELECTED VEIN AND CONFIRM VESSEL ENTRY. B. INSERT SOFT OR GUIDING TIP OF THE GUIDEWIRE THROUGH THE NEEDLE AND INTO THE VEIN TO THE DESIRED POSITION BASED ON CLINICAL PRACTICE GUIDELINES AND STANDARDS OR INSTITUTIONAL POLICY AND PROCEDURE. NOTE: IF USING HYDROPHILIC GUIDEWIRE, FILL THE WIRE HOLDER (HOOP) OR BATHE THE GUIDEWIRE WITH STERILE NORMAL SALINE FOR INJECTION TO ENSURE ACTIVATION OF THE HYDROPHILIC COATING PRIOR TO THE PROCEDURE. THIS MAY NEED TO BE REPEATED DURING THE PROCEDURE BY GENTLY FLUSHING THE CATHETER WITH STERILE NORMAL SALINE SOLUTION FOR INJECTION THROUGH THE SUPPLIED FLUSH ASSEMBLY WITH THE GUIDEWIRE IN PLACE. C. RECOMMENDED TIP LOCATION IS AT OR BELOW THE AXILLARY LINE. PRECAUTION: IF GUIDEWIRE MUST BE WITHDRAWN, REMOVE THE NEEDLE AND GUIDEWIRE AS A SINGLE UNIT. D. GENTLY WITHDRAW SAFETY NEEDLE FROM GUIDEWIRE WHILE HOLDING GUIDEWIRE IN PLACE." A REVIEW OF THE SPECTRUM VASCULAR COMPLAINT SYSTEM NOTED NO ADVERSE TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. REFERENCE CF-48.

    Description of Event or Problem · 0

    AN END-USER EXPERIENCE AN ISSUE WITH A GUIDEWIRE FROM A BIOFLO MIDLINE 4F SL-20CM MAX STERILE BARRIER NURSING KIT W/ TWO NITINOL GUIDEWIRE PG. IT WAS REPORTED THAT, DURING REMOVAL, FRAYING OF THE GUIDEWIRE WAS OBSERVED, AND FRAGMENTS WERE RETAINED WITHIN THE PATIENT'S TISSUE. THE PHYSICIAN WAS ABLE TO RETRIEVE THE RETAINED FRAGMENTS. THERE WERE NO ADVERSE EFFECTS OR PATIENT HARM REPORTED BECAUSE OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2148361 BIOFLO MIDLINE 4F SL-20CM MAX STERILE BARRIER NURSING KIT MIDLINE CATHETER FOZ SPECTRUM VASCULAR N/A 5852703 H965464701

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other