BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-FLO 4F SL 55CM MST-70 KIT VALVED WITH NITINOL GUIDEWIRE PG

    MDR report key: 25191984 · Received May 15, 2026

    Report

    Report Number
    3030714660-2026-00007
    Event Type
    Malfunction
    Date Received
    May 15, 2026
    Date of Event
    April 17, 2026
    Report Date
    May 15, 2026
    Manufacturer
    SPECTRUM VASCULAR
    Product Code
    LJS
    UDI-DI
    H965458910
    PMA / PMN Number
    K150448
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    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 A PICC HUB CRACK WAS CONFIRMED FROM A VISUAL INSPECTION OF A PICTURE SENT BY THE CUSTOMER. IF 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 HUB CRACK 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 FOR THE CRACKED FEMALE VALVE HOUSING IS DUE TO AN OVER TIGHTENED CONNECTION WITH A MATING MALE LUER (LIKELY A NEEDLELESS CONNECTOR) AND/OR INADEQUATE FLUSHING. A CONTRIBUTING FACTOR TO THE OVER-TIGHTENED CONNECTION MAY BE THE MECHANICS/HAND PLACEMENT DURING INFUSION ACCESS. IT IS PREFERABLE TO GRASP THE NEEDLELESS CONNECTOR (NC) WHEN CONNECTING A SYRINGE/TUBING TO IT RATHER THAN GRASPING THE LUER HUB WHILE MAKING A CONNECTION WITH THE NC. GRASPING THE LUER HUB WHILE CONNECTING A SYRINGE/TUBING SET TO THE NC CAN TRANSMIT ADDITIONAL TORQUE TO THE FEMALE LUER HUB. INADEQUATE FLUSHING OF THE DEVICE LUMEN MAY ALSO BE A CONTRIBUTING FACTOR. AN INSTRUCTIONAL VIDEO REGARDING THE CARE AND MAINTENANCE OF THE BIOFLO PICC CAN BE FOUND ON SPECTRUM VASCULAR'S YOUTUBE CHANNEL, "BIOFLO PICC CARE AND MAINTENANCE INSTRUCTIONAL VIDEO" UPLOADED ON SEPTEMBER 24, 2025. THIS VIDEO IS INTENDED AS A VISUAL REPRESENTATION OF INFORMATION PROVIDED IN THE DFU FOR CLINICIANS WHO ARE RESPONSIBLE FOR THE CARE AND MAINTENANCE OF PICCS BUT ARE NOT RESPONSIBLE FOR PICC PLACEMENT. LABELING REVIEW: THE DFU THAT IS SUPPLIED WITH THE PRODUCT (16600224-01) CONTAINS THE FOLLOWING STATEMENTS: PRECAUTIONS IT IS RECOMMENDED THAT ONLY LUER LOCK ACCESSORIES BE USED WITH THE BIOFLO¿ PICC WITH ENDEXO¿ TECHNOLOGY. REPEATED OVER-TIGHTENING MAY REDUCE HUB CONNECTOR LIFE. DO NOT USE HEMOSTATS TO SECURE OR REMOVE DEVICES WITH LUER LOCK HUB CONNECTIONS. FLUSHING - RECOMMENDED PROCEDURE FLUSH THE CATHETER AFTER EVERY USE, OR AT LEAST EVERY SEVEN DAYS WHEN NOT IN USE, TO MAINTAIN PATENCY. USE A 10 ML SYRINGE OR LARGER. FLUSH THE CATHETER WITH A MINIMUM OF 10 ML OF STERILE NORMAL SALINE, USING A "PULSE" OR "STOP/START" TECHNIQUE. WARNING: IF USING BACTERIOSTATIC SALINE, DO NOT EXCEED 30ML IN A 24-HOUR PERIOD. DISCONNECT THE SYRINGE AND ATTACH A STERILE END CAP TO EACH LUER LOCK HUB. NOTE: THIS IS THE RECOMMENDED FLUSH PROCEDURE FOR THIS CATHETER. IF USING A DIFFERENT PROCEDURE THAN LISTED ABOVE, THE USE OF HEPARIN MAY BE NECESSARY. FOLLOW INSTITUTIONAL PROTOCOL FOR CATHETER FLUSHING. PRECAUTION: INCOMPATIBLE DRUG DELIVERY WITHIN THE SAME LUMEN MAY CAUSE PRECIPITATION. ENSURE THAT THE CATHETER LUMEN IS FLUSHED FOLLOWING EACH INFUSION. 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: PLACE A CAP ON THE HUB AFTER USE TO REDUCE THE RISK OF CONTAMINATION. 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: CF-85.

    Description of Event or Problem · 0

    AN END USER REPORTED AN ISSUE WHEN USING THE BIOFLO 4F SL 55CM MST-70 KIT VALVED WITH NITINOL GUIDEWIRE PG. THE HUB WAS OBSERVED TO BE CRACKED ALONG THE LUER THREADS. TREATMENT WAS DELAYED AND THE AFFECTED DEVICE HAD TO BE REMOVED AND REPLACED WITH A DIFFERENT PRODUCT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR HARM BECAUSE OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330884 BIO-FLO 4F SL 55CM MST-70 KIT VALVED WITH NITINOL GUIDEWIRE PG PERIPHERALLY INSERTED CENTRAL CATHETER LJS SPECTRUM VASCULAR 5778059 H965458910

    Patients

    Seq Age Sex Outcome Treatment
    1