BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    132CM CEREGLIDE 71 CATHETER

    MDR report key: 19693056 · Received July 8, 2024

    Report

    Report Number
    3007628272-2024-00038
    Event Type
    Malfunction
    Date Received
    July 8, 2024
    Date of Event
    June 20, 2024
    Report Date
    October 3, 2024
    Manufacturer
    CERENOVUS, INC.
    Product Code
    NRY
    UDI-DI
    10886704085409
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). UPDATED SECTIONS ON THIS MED WATCH: B4, D4 (PRIMARY UDI NUMBER). CORRECTED DATA: D4 (PRIMARY UDI NUMBER). THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). UPDATED SECTIONS ON THIS MED WATCH: B4, B5, D4 (PRIMARY UDI NUMBER), G3, G6, H2, H6 AND H11. PRE-SHIPMENT PICTURES ACCOMPANIED THE COMPLAINT FILE, THE T-CONNECTOR CAN BE APPRECIATED IN GOOD CONDITIONS, THERE IS NO EVIDENCE OF DAMAGE OR DEFORMATION ON BOTH PORTS, ALSO, THE HUB WAS NOTED TO BE UNDAMAGED. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31294255 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE MALFUNCTION WERE IDENTIFIED. THE ISSUE REGARDING A T-CONNECTOR NOT BEING FULLY TIGHTEN CANNOT BE CONFIRMED BASED ON PICTURES SINCE A FUNCTIONAL ANALYSIS NEEDS TO BE PERFORMED, ADDITIONALLY, NO VISIBLE DAMAGES WERE NOTED ON THE T-CONNECTOR THAT CONTRIBUTES TO THE FAILURE REPORTED. THIS INVESTIGATION WAS PERFORMED BASED ONLY ON THE PHOTO PROVIDED. IF THE PRODUCT IS RECEIVED AFTER THIS INVESTIGATION, AN ASSESSMENT WILL BE PERFORMED AS PER THE CONDITIONS OF THE DEVICE RETURNED. AS PART OF THE CERENOVUS QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THEREFORE, NO CAPA ACTIVITY IS REQUIRED. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4). COMPLAINT CONCLUSION: AS REPORTED BY THE FIELD, DURING THE PREPPING OF A 132CM CEREGLIDE 71 CATHETER (NIC71132C, 31294255) AND PRIOR TO INSERTION INTO THE PATIENT¿S BODY, WHEN THE T-CONNECTOR OF THE CG71 ACCESSORY WAS CONNECTED TO THE HUB OF THE CG71, THE PHYSICIAN FELT THE KNOB OF THE T-CONNECTOR WAS NOT FULLY TIGHTEN, AND THE T-CONNECTOR APPEARED NOT STABLE ON THE HUB. THEREFORE, THE T-CONNECTOR WAS NOT USED ON THE PHYSICIAN'S DECISION AND REPLACED WITH ANOTHER NEW Y-CONNECTOR. ADDITIONAL INFORMATION RECEIVED ON 05-JUL-2024 INDICATED THAT THERE WAS NO DAMAGE AT THE CONNECTION SITE. THE Y CONNECTOR COULD BE USED WITH THE DEVICES WITHOUT ANY ISSUES. THERE WAS NO PATIENT INJURY AS THE DEVICE WAS NOT CLINICALLY USED. PRE-SHIPMENT PICTURES ACCOMPANIED THE COMPLAINT FILE, THE T-CONNECTOR CAN BE APPRECIATED IN GOOD CONDITIONS, THERE IS NO EVIDENCE OF DAMAGE OR DEFORMATION ON BOTH PORTS, ALSO, THE HUB WAS NOTED TO BE UNDAMAGED. A NON-STERILE T-CONNECTOR OF A CG71 ACCESSORY WAS RECEIVED CONTAINED IN THE DECONTAMINATION POUCH. UPON RECEIVING THE DEVICE, VISUAL INSPECTION WAS PERFORMED, AND NO APPEARANCE OF DAMAGES WAS NOTED. THE KNOB OF THE T-CONNECTOR WAS INSPECTED AND NO DAMAGES WERE FOUND. THE T-CONNECTOR WAS PAIRED WITH THE LUER HUB OF A LAB-SAMPLE 132CM CEREGLIDE 71 CATHETER, AND NO ISSUES WERE ENCOUNTERED. THE CONNECTION WAS NOT LOOSE NOR DEFECTIVE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31294255 NUMBER, AND NO NON-CONFORMANCES RELATED TO THE MALFUNCTION WERE IDENTIFIED. THE ISSUE REPORTED REGARDING THE T-CONNECTOR NOT BEING FULLY TIGHTENED AND BEING UNSTABLE COULD NOT BE CONFIRMED, AS NO ISSUES WITH THE CONNECTOR WERE ENCOUNTERED. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE ANALYSIS. AS PART OF CERENOVUS QUALITY PROCESS ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. SINCE NO ISSUES WERE IDENTIFIED, NO CAPA ACTIVITY IS REQUIRED. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED TO IDENTIFY STATISTICAL SIGNALS FOR CONSIDERATION OF FURTHER CORRECTION ACTION. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). SECTION E1. INITIAL REPORTER PHONE: (B)(6). SECTION H3 -THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION AND TESTING. HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE. IF THE DEVICE RETURNS, A DEVICE INVESTIGATION WILL BE PERFORMED. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803 (AND/OR PART 4, AS APPLICABLE). THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY CERENOVUS, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, CERENOVUS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    AS REPORTED BY THE FIELD, DURING THE PREPPING OF A 132CM CEREGLIDE 71 CATHETER (NIC71132C, 31294255) AND PRIOR TO INSERTION INTO THE PATIENT¿S BODY, WHEN THE T-CONNECTOR OF THE CG71 ACCESSORY WAS CONNECTED TO THE HUB OF THE CG71, THE PHYSICIAN FELT THE KNOB OF THE T-CONNECTOR WAS NOT FULLY TIGHTEN, AND THE T-CONNECTOR APPEARED NOT STABLE ON THE HUB. THEREFORE, THE T-CONNECTOR WAS NOT USED ON THE PHYSICIAN'S DECISION AND REPLACED WITH ANOTHER NEW Y-CONNECTOR. ADDITIONAL INFORMATION RECEIVED ON 05-JUL-2024 INDICATED THAT THERE WAS NO DAMAGE AT THE CONNECTION SITE. THEY CONNECTOR COULD BE USED WITH THE DEVICES WITHOUT ANY ISSUES. THERE WAS NO PATIENT INJURY AS THE DEVICE WAS NOT CLINICALLY USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151796 132CM CEREGLIDE 71 CATHETER CATHETER, ASPIRATION CATHETER NRY CERENOVUS, INC. 31294255 10886704085409

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown