BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOFLO 5F DL 55CM MST-70 KIT VALVED PG

    MDR report key: 22758676 · Received August 8, 2025

    Report

    Report Number
    3030714660-2025-00008
    Event Type
    Malfunction
    Date Received
    August 8, 2025
    Date of Event
    July 9, 2025
    Report Date
    August 7, 2025
    Manufacturer
    SPECTRUM VASCULAR
    Product Code
    LJS
    UDI-DI
    H965458320
    PMA / PMN Number
    K150448
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE REPORTED DEVICE WAS NOT RETURNED, A DEVICE EVALUATION IS UNABLE TO BE PERFORMED, HOWEVER A PICTURE OF THE HUB CRACK WAS PROVIDED. INVESTIGATION WAS COMPLETED BASED ON INFORMATION RECEIVED TO DATE. IF COMPLAINT SAMPLE IS RECEIVED AND WARRANTS FURTHER INVESTIGATION, THEN COMPLAINT FILE WILL BE REOPENED AND UPDATED ACCORDINGLY. THE CUSTOMER'S COMPLAINT DESCRIPTION IS CONFIRMED FOR PICC HUB CRACKED BASED ON PICTURE PROVIDED. NO COMPONENT MANUFACTURING/MOLDING NONCONFORMANCES OR OTHER DAMAGE WAS OBSERVED DURING VISUAL INSPECTION OF THE PICTURES PROVIDED. A DHR REVIEW OF THE PACKAGING/ASSEMBLY/VALVE LOTS WERE REVIEWED FOR ANY DEVIATIONS RELATED TO THE REPORTED HUB CRACK FAILURE MODE. THE REVIEW CONFIRMS 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; REFERENCE YOUTUBE VIDEO, "ANGIODYNAMICS BIOFLO PICC CARE AND MAINTENANCE INSTRUCTIONAL VIDEO" UPLOADED ON NOVEMBER 18, 2020. 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 DEVICE (IFU: 16600224-01) CONTAINS THE FOLLOWING PRECAUTION: IT IS RECOMMENDED THAT ONLY LUER LOCK ACCESSORIES BE USED WITH THE BIOFLO¿ PICC WITH ENDEXO¿ AND PASV¿ VALVE 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. 1. 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. 2. 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. 3. 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 REVIEW OF SIMILAR COMPLAINTS NOTED NO ADVERSE TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. REFERENCE: (B)(4).

    Description of Event or Problem · 0

    AN END USER EXPERIENCED AN ISSUE WITH A PICC FROM A BIOFLO 5F DL 55 CM MST-70 KIT VALVED. IT WAS REPORTED POST-PLACEMENT THAT THE PICC HUB CRACKED, REQUIRING REMOVAL. THERE WERE NO ADVERSE EFFECTS OR PATIENT HARM REPORTED BECAUSE OF THIS INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2306366 BIOFLO 5F DL 55CM MST-70 KIT VALVED PG PERIPHERALLY INSERTED CENTRAL CATHETER LJS SPECTRUM VASCULAR 5845508 H965458320

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown