MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 16 GA X 6IN (16 CM); CATHETER PERCUTANEOUS

Catalog Number	CV-04306
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Codes	Discomfort (2330); Needle Stick/Puncture (2462)
Date of Event	01/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "in the operating theatre, after inserting the guide into the puncture needle, the guide became stuck." there was delay to therapy.The patient required a second puncture to complete the procedure.There was no medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "in the operating theatre, after inserting the guide into the puncture needle, the guide became stuck." there was delay to therapy.The patient required a second puncture to complete the procedure.There was no medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one guidewire and 18 ga introducer needle along with the lidstock.The guidewire was returned advanced through the 18 ga introducer needle.Signs of use in the form of biological material were observed on the guide wire and inside the needle cannula.Visual inspection revealed that the distal j bend of the guidewire was misshapen, and a single kink was observed on the guidewire body.Microscopic examination confirmed the observed damage and showed that both the distal and proximal welds were full and spherical.The kink in the guide wire measured 325 mm from the proximal tip.The overall length of the guide wire measured 456 mm, which is within the specification limits of 450mm-458mm per guide wire product drawing.The outer diameter of the guide wire measured 0.809 mm, which is within the specification limits of 0.788mm-0.826mm per guide wire product drawing.The outer diameter of the needle cannula measured 0.0502" which is within the specification limits of 0.0495 - 0.0505" per needle cannula product drawing.The inner diameter of the needle cannula measured 0.041", which is within the specification limits of 0.041 - 0.043" per needle cannula product drawing.The guide wire and introducer needle were functionally tested per the product instructions for use (ifu).The ifu provided with this kit instructs the user, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." undue force was required to dislodge the guide wire from the cannula.Upon removal, a large amount of excess biological material was observed on the guidewire and within the cannula.The biological material was completely removed, and the returned guidewire passed through the returned 18 ga introducer needle.Minor resistance was observed at the location of the kink; however, the undamaged portions of the guidewire advanced through the introducer needle without resistance.A manual tug test confirmed that the distal and proximal welds were secure and intact.A device history record review was performed, and no relevant manufacturing issues were identified.The ifu provided with the kit informs the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested." the report of kinking due to guide wire/needle resistance was confirmed through complaint investigation of the returned sample.Visual examination identified one kink on the guidewire body and a misshapen distal j band.Functional testing identified a build-up of excess biological material within the needle cannula.Undue force was required to remove the guidewire from the cannula.After removal of the biological material, the returned guidewire was passed through the returned introducer needle, with minor resistance observed at the kink location while the undamaged portions advanced without resistance.Dimensional inspection confirmed that the guidewire and introducer needle met all applicable specifications.Review of the device history record did not identify any manufacturing-related nonconformances.Based on the customer report and the condition of the returned sample, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 16 GA X 6IN (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: 24344531
• Report Number: 3006425876-2026-00236
• Device Sequence Number: 15911678
• Product Code: DQY
• UDI-Device Identifier: 00801902105172
• UDI-Public: (01)00801902105172(11)250221(17)291031(10)71F25B0727(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): 02/06/2026

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: CV-04306
• Device Lot Number: 71F25B0727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2025
• 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