BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAN 5F DL BIOFLO PASV PICC NURSING TRAY, ST. PAUL'S HOSPITAL (STP)

    MDR report key: 25323575 · Received May 28, 2026

    Report

    Report Number
    3030714660-2026-00010
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Date of Event
    March 16, 2026
    Report Date
    May 29, 2026
    Manufacturer
    SPECTRUM VASCULAR
    Product Code
    LJS
    UDI-DI
    H96560M7009361
    PMA / PMN Number
    K150448
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 DIFFICULTY FLUSHING A CATHETER COULD NOT BE CONFIRMED AS THE PICC WAS DISPOSED OF BEFORE A PICTURE COULD BE TAKEN. A DHR REVIEW OF THE PACKAGING/ASSEMBLY/VALVE LOTS WAS CONDUCTED FOR ANY DEVIATIONS RELATED TO THE REPORTED 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, INCLUDING OVER-PRESSURIZATION OF THE CATHETER TUBING AGAINST AN OCCLUDED LUMEN. THE EVENT REMAINS CONSISTENT WITH KNOWN RISKS ASSOCIATED WITH USE CONDITIONS, AND DOES NOT INDICATE A NEW HAZARD OR HAZARDOUS SITUATION. LABELING REVIEW WAS PERFORMED. THE DFU ADDRESSES THE REPORTED FAILURE MODE AND PROVIDES APPROPRIATE GUIDANCE. THE DFU THAT IS SUPPLIED WITH THE PRODUCT (14600124-01) CONTAINS THE FOLLOWING DIRECTIONS AND PRECAUTIONS: WARNINGS: FAILURE TO ENSURE PATENCY OF THE CATHETER PRIOR TO POWER INJECTION STUDIES MAY RESULT IN CATHETER FAILURE. POWER INJECTOR'S PRESSURE LIMITING (SAFETY CUT-OFF) FEATURE MAY NOT PREVENT OVER-PRESSURIZATION OF OCCLUDED CATHETER. EXCEEDING THE MAXIMUM ALLOWABLE FLOW RATE (TABLE 2) MAY RESULT IN CATHETER FAILURE AND/OR CATHETER TIP DISPLACEMENT. THE MAXIMUM PRESSURE OF POWER INJECTORS USED WITH THE POWER INJECTABLE PICC MUST NOT EXCEED 325 PSI (2,240 KPA). PRECAUTION: IF RESISTANCE IS MET WHEN FLUSHING, IT IS RECOMMENDED THAT NO FURTHER ATTEMPTS BE MADE. FURTHER FLUSHING MAY RESULT IN CATHETER RUPTURE. REFER TO INSTITUTIONAL PROTOCOL FOR CLEARING OCCLUDED CATHETERS. PRECAUTION: NEVER FORCIBLY FLUSH AN OBSTRUCTED LUMEN. IF EITHER LUMEN DEVELOPS A THROMBUS, FIRST ATTEMPT TO ASPIRATE THE CLOT WITH A SYRINGE. IF ASPIRATION FAILS, CONSULT INSTITUTIONAL PROTOCOL FOR MANAGEMENT OF THROMBOSIS. 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 CANADA DISTRIBUTOR REPORTED AN ISSUE WITH A 5F DL BIOFLO PASV PICC. IT WAS REPORTED THAT A PATIENT EXPERIENCED DISCOMFORT WHEN FLUSHING THE GREY LUMEN PLACED IN THE UPPER ARM, WITH POSITIONAL FLOW NOTED. EVALUATION BY THE IV TEAM FOUND NO MECHANICAL OCCLUSION OR KINKING, INCLUDING REVIEW OF A PRIOR CHEST X-RAY. DURING SIMULTANEOUS FLUSHING OF BOTH LUMENS, BULGING WAS OBSERVED APPROXIMATELY 1 CM FROM THE INSERTION SITE. THE PICC WAS REMOVED AND REPLACED, RESULTING IN ADDITIONAL INTERVENTION AND DELAY IN TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455028 CAN 5F DL BIOFLO PASV PICC NURSING TRAY, ST. PAUL'S HOSPITAL (STP) PERIPHERALLY INSERTED CENTRAL CATHETER LJS SPECTRUM VASCULAR 5850710 H96560M7009361

    Patients

    Seq Age Sex Outcome Treatment
    1