BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PREMIERPRO

    MDR report key: 19613246 · Received June 26, 2024

    Report

    Report Number
    19613246
    Event Type
    Malfunction
    Date Received
    June 26, 2024
    Date of Event
    May 14, 2024
    Report Date
    December 4, 2024
    Manufacturer
    MEDSOURCE LABS, LLC
    Product Code
    FOZ
    UDI-DI
    00811220034795
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THREE ATTEMPTS WERE MADE TO CONTACT THE INITIAL REPORTER. NO ACKNOWLEGEMENT OR RESPONSE WAS RECEIVED. NO PRODUCT WAS AVAILABLE TO BE RETURNED FOR EVALUATION AND INVESTIGATION. THE LOT NUMBER INFORMATION THAT WAS PROVIDED WAS "MULTIPLE". DUE TO NOT HAVING SPECIFIC LOT INFORMATION, AN INVESTIGATION WAS PERFORMED ON RETENTION SAMPLES OF 31TB20100, LOT #: 40065/0043 MANUFACTURING DATE: 2024-04-30, EXPIRATION DATE: 2029-03-31. THE BATCH MANUFACTURING RECORDS (BMR) FOR THE REPORTED BATCH WERE REVIEWED. NO NON-CONFORMITIES RELATED TO THE COMPLAINT WERE OBSERVED. REPORTS WERE VERIFIED FOR ANY SUPPLIER OR RAW MATERIAL CHANGES. NO CHANGES WERE INCORPORATED IN THE PROCESS OR MATERIAL. THE FOLLOWING TESTS WERE PERFORMED ON THE CONTROL SAMPLES TO INVESTIGATE THE REPORTED COMPLAINT: 1. VISUAL INSPECTION 2. 6% TAPER TEST 3. GRIPPING OF NEEDLE WITH CATHETER 4. BEVELS HEAL DISTANCE 5. PENETRATION TEST 6. PULL TEST OF THE CATHETER 7. LEAKAGE TEST ADDITIONALLY, POWER INJECTION TESTING HAS BEEN PERFORMED FOR THIS DEVICE AND NO DISCONNECTION WAS OBSERVED IN THE PRODUCT UP TO 550PSI. BASED ON THE ROOT CAUSE ANALYSIS AND THE RESULTS OBTAINED FROM THE TESTS CARRIED OUT ON CONTROL SAMPLES OF 31TB20100, IT IS CONCLUDED THAT THE PRODUCT DOES NOT CONTAIN A MANUFACTURING DEFECT. THE PROBLEM MAY BE RELATED TO THE USER, AS THE PRODUCT MEETS THE SPECIFIED REQUIREMENTS IN THE TESTING. THE REPORTED COMPLAINT MAY BE RELATED TO USER ERROR WITH THE FOLLOWING POSSIBILITIES: DEVICE MAY NOT HAVE BEEN USED AS INTENDED BY THE MANUFACTURER. CATHETER MAY HAVE BEEN DAMAGED OR DEFORMED DUE TO MULTIPLE INSERTION ATTEMPTS BY THE END USER. WRONG SELECTION OF ANATOMICAL LOCATION OF CANNULATION SITE. MATING PART OF THE OTHER DEVICE MAY NOT BE PROPER AND IN COMPLIANCE TO ISO 80369-7.

    Description of Event or Problem · 0

    MULTIPLE ISSUES WITH THE TRUESAFE COMFORT BLOOD CONTROL IV CATHETER. REPORTS CONTAIN ALL GAUGE CATHETERS. VARIOUS COMPLAINTS: 1. CATHETER WOULD NOT ADVANCE 2. CATHETER RETRACTED EARLY CAUSING THE VEIN TO BLOW 3. INFILTRATIONS 4. CATHETER DOES NOT CONNECT TO TUBING CONNECTION WELL 5. DURING PRESSURE INJECTION CT; THE CATHETER AND CONNECTION DISCONNECT. 6. IV NEED WOULD NOT RETRACT AFTER STARTING IV. HAD TO PULL THE ENTIRE DEVICE OUT OF THE PATIENT'S ARM TO RETRACT THE NEEDLE.

    Description of Event or Problem · 0

    MULTIPLE ISSUES WITH THE TRUESAFE COMFORT BLOOD CONTROL IV CATHETER. REPORTS CONTAIN ALL GAUGE CATHETERS. VARIOUS COMPLAINTS: 1. CATHETER WOULD NOT ADVANCE. 2. CATHETER RETRACTED EARLY CAUSING THE VEIN TO BLOW 3. INFILTRATIONS. 4. CATHETER DOES NOT CONNECT TO TUBING CONNECTION WELL. 5. DURING PRESSURE INJECTION CT; THE CATHETER AND CONNECTION DISCONNECT. 6. IV NEED WOULD NOT RETRACT AFTER STARTING IV. HAD TO PULL THE ENTIRE DEVICE OUT OF THE PATIENT'S ARM TO RETRACT THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679507 PREMIERPRO CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ MEDSOURCE LABS, LLC 31TB20100 MULTIPLE 00811220034795

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown