MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW VESSEL CATH SET: 24 GA X 9CM; CATHETER, PERCUTANEOUS

Model Number	IPN918734
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "central catheter inserted by surgeons on the operating table.Jugular vein venectomy was performed.After about a day, it was noticed that the catheter was leaking.Slight damage to the body of the central catheter.The catheter was leaking about the last centimeter.The catheter was removed.The catheter is waiting to be collected." the patients current condition was originally reported as "fine".However, additional information reports the patient is now "deceased".It was reported "the cvc was not the cause of patient's death".Associated mdr numbers include: 3006425876-2025-00455.
Event or Problem Description
It was reported "central catheter inserted by surgeons on the operating table.Jugular vein venectomy was performed.After about a day, it was noticed that the catheter was leaking.Slight damage to the body of the central catheter.The catheter was leaking about the last centimeter.The catheter was removed.The catheter is waiting to be collected." the patients current condition was originally reported as "fine".However, additional information reports the patient is now "deceased".It was reported "the cvc was not the cause of patient's death".Associated mdr numbers include: 3006425876-2025-00455 and 3006425876-2025-00456.
Additional Manufacturer Narrative
(b)(4).The customer returned one 1-l cvc catheter for analysis.Signs of use were observed on the catheter body.Visual inspection of the catheter revealed that the catheter body appeared typical.There was no clear visual evidence of any cuts, tears, or damage to the catheter body.Based on the functional testing that was performed, it was identified that there was a small leak from within the catheter hub near the juncture of the proximal catheter body.Further microscopic inspection of the leak site did not reveal any evidence of contact with sharps.The catheter body length from the juncture hub to the distal tip measured 3 5/16", which is within the specifications of 3 1/16" - 3 9/16" per catheter product drawing.The catheter body outer diameter measured 0.0295" , which is within the specifications of 0.029"-0.033" per catheter extrusion product drawing.The inner diameter of the catheter tip measured 0.022", which is within the specifications of 0.020"-0.024" per catheter extrusion product drawing.Functional inspection of the returned catheter was performed per the product ifu which states, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the catheter was flushed using a lab inventory syringe.When flushing the catheter, it was observed that there was a slow occurring leak at the catheter hub near the juncture with the catheter body.A device history record review was performed with no relevant findings identified.The instructions for use (ifu) provided with the kit warns the user, "ensure catheter patency prior to use.Do not use syringes smaller than 10 ml to reduce risk of intraluminal leakage or catheter rupture.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." the customer report of a catheter body leak in use was confirmed through complaint investigation of the returned sample.Although no damage was initially identified during visual inspection, functional inspection revealed that there was a small leak from within the catheter hub near the juncture of the proximal catheter body.Further microscopic inspection of the leak site did not reveal any evidence of contact with sharps.The returned catheter met all relevant dimensional requirements, and a device history record review was performed with no findings.However, based on the investigation performed on the returned sample, the likely root cause is manufacturing related.A non-conformance has been initiated to the manufacturing site to further valuate the issue.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW VESSEL CATH SET: 24 GA X 9CM
• Common Device Name: CATHETER, PERCUTANEOUS
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22003487
• Report Number: 3006425876-2025-00456
• Device Sequence Number: 20610392
• Product Code: DQY
• UDI-Device Identifier: 00801902009913
• UDI-Public: (01)00801902009913(11)230125(17)260430(10)71F23A0697(21)
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K810962
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2026
• Device Model Number: IPN918734
• Device Catalogue Number: ES-04650
• Device Lot Number: 71F23A0697
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/25/2023
• 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: NOT REPORTED; NOT REPORTED
• Patient Age: 28 DA
• Patient Sex: Female
• Patient Weight: 1 KG