MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 12 FR X 16 CM; CATHETER PERCUTANEOUS

Model Number	IPN919472
Medical Device Problem Codes	Crack (1135); Migration (4003)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	03/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that "the suture wings of the 3-lumen central venous catheter were cracked and could no longer secure the catheter in place."additional information received states "there was no serious clinical consequences as we reacted quickly and manual compression was immediately applied to the puncture site.However, the patient lost an amount of blood equivalent to one unit of packed red blood cells, as the dialysis session could not be reinfused; therefore, a blood transfusion was required.A new catheter was inserted.The patient's current condition is unknown at this time.
Additional Manufacturer Narrative
Qn: (b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one, 3-lumen cvc for analysis.Signs of use in the form of biological material were observed on and within the catheter body.Visual analysis of the catheter revealed that both suture wings on the rotating hub were torn/cut.Microscopic analysis revealed the edges of the tear appeared smooth and uniform, which suggests contact with a sharp instrument.The edges of the wings did not appear stretched or deformed.There were no remnants of sutures nor adhesive found on the wings.The catheter length from the distal tip to the juncture hub measured 167 mm, which is within the specification limits of 157-177 mm per catheter product drawing.The catheter outer diameter measured 4.05 mm, which is within the specification limits of 3.96-4.06 mm per catheter extrusion product drawing.Functional testing of the suture wings on the catheter could not be functionally tested due to damage to each wing.The catheter was functionally tested per the product 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)." a lab inventory syringe filled with water was used to flush each lumen and each lumen flush as intended with no signs of blockages or leaks.R & d was contacted as a part of this complaint investigation.Previous attempts to replicate the fa ilure mode revealed a significant amount of force would be required to break the suture wing.Previous testing was performed on lab inventory catheters where a braided non-absorbable silk 000 suture (common suture choice in the clinical setting) was secured to the wing and undue force was applied to replicate the damage observed in the sample received.Only the suture thread broke in the first test, and the wing broke during the second test with the wing being severely stretched/deformed before the break.Therefore, the damage shown in the returned sample could not be replicated using undue force.It was also observed that the damage on the suture wing appears very uniform and straight which suggests contact with sharps prior to the rest of the material tearing off.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "use a catheter stabilization device, catheter clamp and fastener, staples or sutures (where provided).Use catheter hub as primary securement site." a catheter clamp and fastener is not included in finished good (b)(4); therefore, the primary securement site is the catheter hub.The ifu also warns 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." the customer report of a catheter migration was confirmed through information from the customer and investigation of the returned sample.The primary suture location for this catheter is the juncture hub using the rotating hub wings, and visual analysis of the catheter revealed that both suture wings on the rotating hub were torn/cut.The customer did not provide additional information regarding the securement methods of the catheter.Based on the sample receive and consultation with r & d, it is unknown whether contact with sharps, undue force, a combination of the two, or another factor caused or contributed to the reported event.Based on the customer report and the sample received, unintentional use error likely caused or contributed to the reported event.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported that "the suture wings of the 3-lumen central venous catheter were cracked and could no longer secure the catheter in place."additional information received states "there was no serious clinical consequences as we reacted quickly and manual compression was immediately applied to the puncture site.However, the patient lost an amount of blood equivalent to one unit of packed red blood cells, as the dialysis session could not be reinfused; therefore, a blood transfusion was required.A new catheter was inserted.The patient's current condition is unknown at this time.

• Brand Name: ARROW CVC SET: 3-LUMEN 12 FR X 16 CM
• 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: 24830476
• Report Number: 3006425876-2026-00416
• Device Sequence Number: 10447034
• Product Code: DQY
• UDI-Device Identifier: 00801902102119
• UDI-Public: (01)00801902102119(11)241211(17)291130(10)71F24M0327(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2026

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: IPN919472
• Device Catalogue Number: CS-12123-F
• Device Lot Number: 71F24M0327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 04/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2024
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown