BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIO-STABLE 3F SL-55CM MST-70 KIT VALVED

    MDR report key: 21499562 · Received March 1, 2025

    Report

    Report Number
    3030714660-2025-00004
    Event Type
    Malfunction
    Date Received
    March 1, 2025
    Date of Event
    January 30, 2025
    Report Date
    February 27, 2025
    Manufacturer
    SPECTRUM VASCULAR
    Product Code
    LJS
    UDI-DI
    H965458020
    PMA / PMN Number
    150448
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS THE REPORTED DEVICE WAS NOT RETURNED, A DEVICE EVALUATION IS UNABLE TO BE PERFORMED, 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. 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. LABELING REVIEW: THE DFU THAT IS SUPPLIED WITH THE DEVICE (IFU: (B)(6)) 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 BIO-STABLE 3F SL-55CM MST-70 KIT VALVED. IT WAS REPORTED POST PLACEMENT, THAT THE PICC HUB CRACKED, REQUIRING REMOVAL. 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
    611548 BIO-STABLE 3F SL-55CM MST-70 KIT VALVED PERIPHERALLY INSERTED CENTRAL CATHETER LJS SPECTRUM VASCULAR 5820059 H965458020

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown