BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JELCO PROTECTIV FEP STRAIGHT SAFETY CATHETER

    MDR report key: 20798532 · Received November 27, 2024

    Report

    Report Number
    1219611-2024-00057
    Event Type
    Malfunction
    Date Received
    November 27, 2024
    Date of Event
    October 30, 2024
    Report Date
    April 23, 2025
    Manufacturer
    SMITHS MEDICAL ASD, INC.
    Product Code
    FOZ
    UDI-DI
    10351688071118
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D9. DATE RETURNED TO MFG: 24-FEB-2025. H6. INVESTIGATION CODES: UPDATED. INVESTIGATION SUMMARY: ONE HUNDRED AND FOUR (104) UNOPENED, UNUSED 22G X 1¿ PROTECTIV SISTER SAMPLES (SKU# 305006, LOT# 6021646) WERE RETURNED FOR ANALYSIS. FORTY RANDOM SAMPLES OF THE RETURNED 104 SISTER SAMPLES WERE VISUALLY EXAMINED FOR CRACKED CATHETER HUB, EYELET-TO-TUBE TEARS, PUNCTURED CATHETER, MISSING ADHESIVE AND DAMAGED/MISSING POROUS BARRIER. TWENTY OF THE VISUALLY INSPECTED 40 SAMPLES WERE TESTED FOR CATHETER LEAKAGE AND THE REMAINING TWENTY FOR FLUID POOLING. ALL EVALUATED SAMPLES WERE FOUND TO BE ACCEPTABLE WITHOUT FAILURE. BASED ON ANALYSIS, THE COMPLAINT CANNOT BE CONFIRMED AS A MANUFACTURING NONCONFORMANCE. IN PROCESS, PRODUCT IS EVALUATED FOR CATHETER LEAKAGE AND FLUID POOLING AND VISUALLY INSPECTED BY OPERATORS USING STATISTICALLY VALID SAMPLING PLANS AT DEFINED INTERVALS. IF ANY NONCONFORMANCES ARE FOUND IN PROCESS, THE PRODUCT IS ISOLATED, NON-CONFORMED AND IMMEDIATE ACTION IS TAKEN TO PERFORM CORRECTIONS. SAMPLING PLANS ARE BASED ON RANDOM SAMPLING SELECTION AND ARE DESIGNED TO PROVIDE A HIGH LEVEL OF ASSURANCE THAT THE TRUE FRACTION DEFECTIVE IS LESS THAN OR EQUAL TO THE ESTABLISHED AQL (ACCEPTABLE QUALITY LIMIT) LEVEL FOR EACH QUALITY CHARACTERISTIC. IN PROCESS, TO ASSURE THAT OUR PRODUCTS MEET FUNCTIONAL REQUIREMENTS, THE DIMENSIONS OF THE CATHETER COMPONENTS (EYELET/ACTUATOR, TUBING, AND HUB) ARE TIGHTLY CONTROLLED. DURING MANUFACTURE, OUR CATHETERS ARE TESTED TO ASSURE THAT THE TUBING WILL NOT TEAR, BREAK OR OTHERWISE FAIL. DURING MANUFACTURE, CRITICAL PARAMETERS ARE 100% CONTROLLED DURING THE DIFFERENT PHASES. ONCE ASSEMBLED FROM THE TUBE, EYELET/ACTUATOR AND HUB, THE CATHETERS ARE INSPECTED IN-PROCESS 100% TO DEMONSTRATE THAT THE CATHETER TUBE IS PROPERLY SECURED TO THE HUB. AS REPORTED, THE REPORTED EVENT COULD NOT BE VERIFIED AND/OR CONFIRMED WITH CONFIDENCE, THEREFORE, NO FURTHER CORRECTION, CORRECTIVE OR PREVENTIVE ACTIONS WILL BE CONDUCTED BY THE MANUFACTURING FACILITY AT THIS TIME. COMPLAINT INFORMATION WILL CONTINUE TO BE MONITORED. ICU MEDICAL REGULARLY REVIEWS AND ANALYZES POST-MARKET DATA FOR NEW INFORMATION OR ADVERSE TRENDS, IMPLEMENTING CORRECTIONS, TAKING CORRECTIVE AND PREVENTATIVE ACTIONS ACCORDINGLY. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) SHOWS THERE WERE NO OBSERVATIONS OR NONCONFORMITIES RECORDED DURING MANUFACTURE TO SUGGEST AN ISSUE OF THIS NATURE WOULD OCCUR WITH THIS LOT OF PRODUCTS.

    Additional Manufacturer Narrative · 0

    H3. REASON DEVICE NOT EVALUATED BY MFG: OTHER; DEVICE WAS NOT RETURNED TO MANUFACTURER. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CATHETER LEAKED DURING USE WITH THE PATIENT. THERE WAS NO PATIENT HARM/ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878218 JELCO PROTECTIV FEP STRAIGHT SAFETY CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ SMITHS MEDICAL ASD, INC. 6021646 10351688071118

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown