MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC KIT: 3 LUMEN 12 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CA-25123-F
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "on (b)(6) 2024, the catheter was found leak during use on the patient." the user changed to a new set.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned two photos and one video showing a cvc catheter whilst inside the patient.Visual analysis of the photos clearly showed that the distal extension line was missing from the catheter.This resulted in leaking as it is seen in the customer supplied video.The customer returned one cvc catheter.Signs-of-use in the form of biological material were observed inside the extension lines.Visual analysis revealed that the distal extension line was severed from the juncture hub.The severed line was not returned.Microscopic examination confirmed the separation and revealed that a section of the extrusion was still inside the juncture hub.Visual analysis could not be performed on the separated line as it was not returned.The length of the catheter body measured 215mm, which is within the specification limits of 207mm-227mm per the catheter product drawing.The distal extension line inner diameter measured 1.143mm, which is within the specification limits of 1.140mm-1.240mm per the distal extension line extrusion product drawing.Dimensional analysis could not be performed to verify the outer diameter as the severed line was not returned.The catheter was functionally tested per the instructions-for-use (ifu).The ifu provided with this kit in-structs the user, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)".No leaking or blockages were observed when the proximal and medial extension lines were flushed.Fluid leaked from the respective exit points on the distal end.The returned catheter was then tested 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 lab leak tester and pressurized to 300 kpa for 30 seconds with the distal end 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.Leak testing cannot be performed on the severed distal line as it was not returned.A manual tug test confirmed that the returned extension lines were secure within their respective luer hubs.A device history record review was performed, and no relevant findings were identified.The report of a separated extension line from the juncture hub was confirmed through complaint investigation.Visual analysis revealed that the distal line was severed directly adjacent to the juncture hub, however, the separated extension line was not re-turned for evaluation.A portion of the distal extension line extrusion was still molded inside the juncture hub.The medial and proximal line passed functional leak testing performed, and no evidence of leakage, backflow, or inter-lumen crossover was observed.A device history record review was per-formed, and no relevant findings were identified.Based on the customer report and without the severed line returned for analysis, the root cause cannot be determined.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "on (b)(6) 2024, the catheter was found leak during use on the patient." the user changed to a new set.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW CVC KIT: 3 LUMEN 12 FR X 20 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20646537
• Report Number: 9680794-2024-01094
• Device Sequence Number: 18018949
• Product Code: FOZ
• UDI-Device Identifier: 10801902157932
• UDI-Public: (01)10801902157932(11)240207(17)250411(10)33F23L0134(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K900263
• 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,Followup
• Report Date (Section B): 10/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 04/11/2025
• Device Catalogue Number: CA-25123-F
• Device Lot Number: 33F23L0134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2024
• Supplement Date Received by Manufacturer: 11/26/2024
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 11/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2024
• 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; NONE REPORTED
• Patient Sex: Unknown