MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTILUMEN CVC KIT: 2L 8 FR X 16 CM; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	CDC-42802-P1A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "dilator crumpled on two cvc kits on different dates with different lot numbers.Same thing happened on both cases.The inserter started pushing the dilator into the patient and the dilator crumpled.Pt ok and they were able to get the cvcs in.They have the dilators to send in." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".Associate mdr numbers include: 9680794-2026-00262.
Event or Problem Description
It was reported "dilator crumpled on two cvc kits on different dates with different lot numbers.Same thing happened on both cases.The inserter started pushing the dilator into the patient and the dilator crumpled.Pt ok and they were able to get the cvcs in.They have the dilators to send in." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".Associate mdr numbers include: 9680794-2026-00262 and 9680794-2026-00261.
Additional Manufacturer Narrative
(b)(4).The customer returned one dilator and lidstock for analysis.Signs of use in the form of biological material were observed.Visual analysis revealed that the dilator tip was split and folded.Microscopic examination confirmed the damage.When performing functional testing, particulate was observed exiting the dilator extrusion.This particulate appears to resemble the dilator extrusion.No other defects or anomalies were observed.Further analysis of the msk product drawing (cdc-42802-p1a rev04) revealed that the dilator tip comes into contact with the catheter over needle component.The dilator length measured 4 1/16", which is within the specification limits of 3 3/4"-4 1/4" per the dilator product drawing.The dilator outer diameter measured 0.1185", which is within the specification limits of 0.1170"-0.1200" per the dilator extrusion product drawing.The dilator inner diameter (at the proximal end) measured 0.052", which is within the specification limits of 0.051"-0.055" per the dilator extrusion product drawing.The inner diameter at the distal tip could not be accurately measured due to the damage.A lab inventory guide wire (outer diameter measured 0.079"; was inserted through the dilator tip.Minor resistance was encountered at the dilator tip; however, the guide wire passed through all other sections with no resistance.Performed per ifu statement, "use tissue dilator to enlarge tissue tract to the vein as required.Follow the angle of the guidewire slowly through the skin".A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".The customer report of a damaged dilator tip was confirmed through complaint investigation.Visual analysis revealed that the dilator tip was split and folded.The sample met all relevant dimensional and functional requirements.The root cause cannot be determined at this time; however, a non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW MULTILUMEN CVC KIT: 2L 8 FR X 16 CM
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24804378
• Report Number: 9680794-2026-00261
• Device Sequence Number: 9944768
• Product Code: LRS
• UDI-Device Identifier: 30801902117107
• UDI-Public: (01)30801902117107(11)251118(17)270808(10)33F25J0990(21)
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2026

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 Catalogue Number: CDC-42802-P1A
• Device Lot Number: 33F25J0990
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2025
• 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