MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 8.5FR X 20CM; CATHETER, INTRAVASCULAR, THERAPEUTIC

Model Number	IPN918647
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477)
Date of Event	09/13/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Qn # (b)(4).The customer returned one 3-l catheter for analysis.Definite signs of use in the form of biological material were observed within the catheter body near the distal tip.Visual analysis of the catheter revealed no obvious defects or anomalies.No kinks were identified in the extension lines or catheter body.The overall length of the catheter measured 213mm, which is within the specification limits of 208.5mm-225mm per the catheter product drawing.The outer diameter (od) of the catheter measured 2.87mm which is within the specification limits of 2.85mm-2.95mm per the catheter extrusion graphic.The od of the proximal extension line measured 2.16mm, which is within the specification limits of 2.13-2.21mm per the proximal extension line drawing.The inner diameter (id) of the proximal extension line measured approximately 1.50mm, which is within the specification limits of 1.42mm-1.50mm per the extension line product drawing.The catheter was functionally tested per the instructions-for-use (ifu).The ifu provided with this kit instructs the user, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." all three lumens were flushed using a lab inventory syringe, and all lumens flushed as intended.No signs of a blockage or leaking were observed.The returned catheter was then tested per bs en iso 10555-1 annex c which states that there shall be no liquid leakage in the form of one or more falling drops when pressurized to 300 kpa for 30 seconds.The device was connected to a lab leak tester and pressurized to 300 kpa for 30 seconds with the distal end of the catheter occluded.The extension lines were connected individually to the leak tester, and when pressurized, no catheter backflow or leaks were detected from any portion of the catheter , which indicates no inter lumen crossover was observed.Therefore, the sample passed functional testing.A manual tug test confirmed that all three extension lines were secure within their respective hubs.Additionally, a long pin gauge was inserted into the proximal extension line to determine if any small blockages could be identified.There was no observed resistance during the insertion, indicating that there was no blockage within the lumen.Although there is no evidence of a blocked extension line, the circumstances during use of the device are unknown to determine if there was a blockage , obstruction or occlusion while the device was in use.Therefore, the root cause of this event cannot be determined.A device history record review was performed and no relevant findings were identified.The ifu provided with this kit informs the user, "do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations.Check lumen patency by attaching a syringe to each extension line and aspirate until free flow of venous blood is observed.Flush lumen(s) to completely clear blood from catheter." the customer report of a blocked extension line was not confirmed through complaint investigation of the returned sample.The report of an occlusion in the proximal lumen could not be reproduced during lab testing of the returned device as the proximal extension line flushed as expected during patency testing.The catheter met all relevant dimensional and functional requirements including patency testing and leak testing performed per iso 10555-1.A device history record review was performed, and no relevant findings were identified to suggest a manufacturing issue.Although there were no visual, dimensional, or functional defects identified during inspection of the returned device, the circumstances of use of the device cannot be confirmed to determine if there was a blockage, obstruction or occlusion during use of the device.Therefore, the root cause of this event cannot be determined.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported that "patient under noradrenaline on the proximal line, overpressure of the electric syringe pump where the noradrenaline is being provided therefore treatment is interrupted.There was a significant decrease of arterial pressure (systole at 5 map at 40), desaturation down at 78% (patient intubated, sedated, ventilated at 100% fio2).The noradrenaline was urgently provided on the medial line." furthermore, it was reported "after infusing the nad on the median line, we quickly regained a satisfactory mediale blood pressure." the patient was transferred to the icu department.Additional information reports "the patient showed no particular signs or symptoms following this event." the patient's current status is reported as "stable".

• Brand Name: ARROW CVC SET: 3-LUMEN 8.5FR X 20CM
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: keona jones ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20438703
• Report Number: 3006425876-2024-00964
• Device Sequence Number: 20830671
• Product Code: DQY
• UDI-Device Identifier: 10801902029017
• UDI-Public: (01)10801902029017(11)230629(17)280131(10)71F23F1774(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN918647
• Device Catalogue Number: CS-15853
• Device Lot Number: 71F23F1774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 10/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED
• Patient Sex: Unknown