MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATH SET: 22GA X 8CM; CATHETER PERCUTANEOUS

Catalog Number	SAC-00822-PBX
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "when performing the catheterization, the bent guide is observed." there was no patient harm or injury.No medical intervention required.The patient's current condition is unknown.
Additional Manufacturer Narrative
(b)(4).The customer reported a kinked guidewire associated with an arterial catheterization set.One photograph was provided for evaluation.Visual inspection of the customer-supplied image did not confirm the reported issue.The image showed the catheterization set and packaging with no visible damage, and no kinks were observed on the exposed portion of the guidewire.A complete visual inspection could not be performed because the device was not returned.Dimensional and functional testing could not be conducted due to the absence of a returned sample.No additional testing was performed.A review of the device history record was conducted, and no relevant manufacturing or quality issues were identified.Based on the available information, the reported event could not be confirmed and the root cause can not be determined.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "when performing the catheterization, the bent guide is observed." there was no patient harm or injury.No medical intervention required.The patient's current condition is unknown.

• Brand Name: ARROW ARTERIAL CATH SET: 22GA X 8CM
• 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24574792
• Report Number: 3006425876-2026-00282
• Device Sequence Number: 16070933
• Product Code: DQY
• UDI-Device Identifier: 10801902129915
• UDI-Public: (01)10801902129915(11)250701(17)300630(10)71F25F1306(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K171146
• 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): 02/13/2026

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: SAC-00822-PBX
• Device Lot Number: 71F25F1306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2026
• Supplement Date Received by Manufacturer: 04/03/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2025
• 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