BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 24322902 · Received February 12, 2026

    Report

    Report Number
    3030714660-2026-00001
    Event Type
    Malfunction
    Date Received
    February 12, 2026
    Date of Event
    January 15, 2026
    Report Date
    February 12, 2026
    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
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT OF A 'GUIDEWIRE WILL NOT GO BACK THROUGH THE SHEATH ' COULD NOT BE CONFIRMED, AS NO COMPLAINT SAMPLE OR PHOTOGRAPHIC EVIDENCE WAS PROVIDED BY THE CUSTOMER. IN THE ABSENCE OF THIS EVIDENCE, A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT CANNOT BE DETERMINED. DHR REVIEW OF THE PACKAGING/ACCESSORY LOTS REVEALED NO QUALITY RELATED ISSUES OR MANUFACTURING DEFICIENCIES AT THE TIME OF MANUFACTURE. A REVIEW OF THE DEVICE LABELING, INCLUDING THE DIRECTIONS FOR USE (DFU) AND PRODUCT LABELS, DID NOT IDENTIFY ANY DEFICIENCIES OR INCONSISTENCIES. LABELING REVIEW: THE DFU THAT IS SUPPLIED WITH THE DEVICE (14600281-01 REV 02) 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 YOUR SALES 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. 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. INSTRUCTIONS FOR USE CATHETER INSERTION DIRECTIONS PATIENT PREPARATION 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. PREPARE STERILE FIELD AND SUPPLIES. PREPARE INSERTION SITE AND SURROUNDING AREA WITH AN ACCEPTABLE TOPICAL ANTIMICROBIAL CLEANSING AGENT ACCORDING TO INSTITUTIONAL PROTOCOL, POLICIES AND PROCEDURES. VENOUS ACCESS ACCESS VEIN USING THE APPROPRIATE METHOD BELOW. USING GUIDEWIRE INSERT INTRODUCER NEEDLE, BEVEL UP, INTO SELECTED VEIN AND CONFIRM VESSEL ENTRY. 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. 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. GENTLY WITHDRAW SAFETY NEEDLE FROM GUIDEWIRE WHILE HOLDING GUIDEWIRE IN PLACE." A REVIEW OF SIMILAR COMPLAINTS OVER THE PAST 24 MONTHS NOTED NO ADVERSE TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR ADVERSE TRENDS. REFERENCE CF-57

    Description of Event or Problem · 0

    AN END-USER EXPERIENCED 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, AFTER MIDLINE INSERTION, RESISTANCE WAS FELT WHILE PULLING THE GUIDEWIRE BACK THROUGH THE SHEATH. THE ENTIRE SHEATH WAS PULLED FROM THE PATIENT, AND NO PRODUCT WAS RETAINED. UPON INSPECTION OF THE COMPONENTS REMOVED FROM THE PATIENT, THE GUIDEWIRE COULD NOT BE ADVANCED BACK THROUGH THE SHEATH AND HAD CAUSED DAMAGE TO THE INTRODUCER DURING ATTEMPTED WITHDRAWAL. THERE WERE NO ADVERSE EFFECTS OR PATIENT HARM REPORTED BECAUSE OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127791 BIOFLO MIDLINE 4F SL-20CM MAX STERILE BARRIER NURSING KIT MIDLINE CATHETER FOZ SPECTRUM VASCULAR 5846084 H965464701

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other