BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOFLO 4F SL 55CM MST-70 KIT VALVED PG

    MDR report key: 25211762 · Received May 18, 2026

    Report

    Report Number
    3030714660-2026-00006
    Event Type
    Malfunction
    Date Received
    May 18, 2026
    Date of Event
    February 17, 2026
    Report Date
    May 18, 2026
    Manufacturer
    SPECTRUM VASCULAR
    Product Code
    LJS
    UDI-DI
    H965458120
    PMA / PMN Number
    K150448
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE REPORTED DEVICE WAS NOT RETURNED, A DEVICE EVALUATION IS UNABLE TO BE PERFORMED. THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION OF CATHETER TIP MALPOSITION WITH SUBSEQUENT COILING WAS CONFIRMED BY THE IMAGE PROVIDED BY THE DISTRIBUTOR. IF THE COMPLAINT SAMPLE IS RECEIVED AND WARRANTS FURTHER INVESTIGATION, THEN THE COMPLAINT FILE WILL BE REOPENED AND UPDATED ACCORDINGLY. A DHR REVIEW OF THE PACKAGING/ASSEMBLY/VALVE LOTS WAS CONDUCTED FOR ANY DEVIATIONS RELATED TO THE REPORTED CATETHER MALPOSITION FAILURE MODE. THE REVIEW CONFIRMED THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS WITH NO INTERNAL NON-CONFORMANCE REPORTS (NCR) WRITTEN. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT IS ATTRIBUTABLE TO USE-RELATED FACTORS, SPECIFICALLY EITHER FORCEFUL/INCORRECT FLUSHING TECHNIQUE OR PATIENT MOVEMENT RESULTING IN CATHETER TIP DISPLACEMENT. THE EVENT REMAINS CONSISTENT WITH KNOWN RISKS ASSOCIATED WITH CATHETER PLACEMENT, PATIENT PHYSIOLOGY, AND USE CONDITIONS, AND DOES NOT INDICATE A NEW HAZARD OR HAZARDOUS SITUATION. LABELING REVIEW: LABELING REVIEW WAS PERFORMED. THE DFU ADDRESSES THE REPORTED FAILURE MODE AND PROVIDES APPROPRIATE GUIDANCE. THE DFU THAT IS SUPPLIED WITH THE PRODUCT (16600224-01) CONTAINS THE FOLLOWING DIRECTIONS AND PRECAUTIONS: -IF CATHETER AND ACCESSORIES SHOW ANY SIGN OF DAMAGE (CRIMPED, CRUSHED, CUT, ETC.), DO NOT USE. -DO NOT FULLY INSERT CATHETER UP TO SUTURE WING. -AVOID SHARP OR ACUTE ANGLES DURING INSERTION WHICH MAY COMPROMISE CATHETER FUNCTIONALITY. -FOLLOWING INSTITUTIONAL POLICY, SECURE CATHETER EXTERNALLY TO PREVENT CATHETER MOVEMENT, MIGRATION, DAMAGE, KINKING OR OCCLUSION. -DO NOT PLACE THE CATHETER INTO THE RIGHT ATRIUM OR THE RIGHT VENTRICLE OF THE HEART -AVOID SHARP OR ACUTE ANGLES DURING INSERTION WHICH MAY COMPROMISE CATHETER FUNCTIONALITY. -IF PLACING CATHETER AT PATIENT BEDSIDE TURN PATIENT'S HEAD TOWARD INSERTION SIDE WITH CHIN TO SHOULDER. -SLOWLY AND INCREMENTALLY, INSERT CATHETER ASSEMBLY THROUGH THE PEELABLE SHEATH TO DESIRED TIP LOCATION A TREND ANALYSIS WAS CONDUCTED FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY WITH NO ADVERSE TRENDS NOTED. WE WILL CONTINUE TO MONITOR THIS COMPLAINT TYPE FOR ANY ADVERSE TRENDS. REFERENCE (B)(4).

    Description of Event or Problem · 0

    A UK DISTRIBUTOR REPORTED AN ISSUE WITH A BIO-FLO 4F SL 55CM MST-70 KIT VALVED PG. IT WAS REPORTED THAT THE PICC COILED IN THE RIGHT SUBCLAVIAN VEIN. THE PATIENT HAD TO HAVE NEW PICC INSERTED AND PREVIOUS PICC REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191271 BIOFLO 4F SL 55CM MST-70 KIT VALVED PG PERIPHERALLY INSERTED CENTRAL CATHETER LJS SPECTRUM VASCULAR 5850053 H965458120

    Patients

    Seq Age Sex Outcome Treatment
    1