BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-STABLE 5F DL 55CM MST-70 KIT VALVED PG

    MDR report key: 23887823 · Received December 24, 2025

    Report

    Report Number
    3030714660-2025-00013
    Event Type
    Malfunction
    Date Received
    December 24, 2025
    Date of Event
    November 13, 2025
    Report Date
    December 16, 2025
    Manufacturer
    SPECTRUM VASCULAR
    Product Code
    LJS
    UDI-DI
    H965458320
    PMA / PMN Number
    K150448
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION OF A PICC HUB CRACK WAS CONFIRMED FROM A VISUAL INSPECTION OF A PICTURE SENT BY THE CUSTOMER. DHR REVIEW OF THE PACKAGING/ACCESSORY LOTS REVEALED NO QUALITY RELATED ISSUES OR MANUFACTURING DEFICIENCIES AT THE TIME OF MANUFACTURE. 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. 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 SPECTRUM VASCULAR'S YOUTUBE VIDEO, "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 (1660224-01) CONTAINS THE FOLLOWING STATEMENTS: PRECAUTIONS 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. INVESTIGATION WAS COMPLETED BASED ON INFORMATION RECEIVED TO DATE. IF ADDITIONAL INFORMATION IS RECEIVED AND WARRANTS FURTHER INVESTIGATION, THEN THE COMPLAINT FILE WILL BE REOPENED AND UPDATED ACCORDINGLY. REFERENCE: (B)(4).

    Description of Event or Problem · 0

    AN END USER REPORTED AN ISSUE WHEN USING THE BIO-FLO 5F DL 55CM MST-70 KIT VALVED PG. THE GRAY HUB WAS OBSERVED TO BE CRACKED ALONG THE LUER THREADS. 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
    2508143 BIO-STABLE 5F DL 55CM MST-70 KIT VALVED PG PERIPHERALLY INSERTED CENTRAL CATHETER LJS SPECTRUM VASCULAR 5827436 H965458320

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention