MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW RA CATH SET: 22 GA X 1-3/8IN; WIRE GUIDE CATHETER

Catalog Number	RA-04122
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that "piece of needle broke off in patient wrist".The patient was transferred 24 hours after the event and will no consultation for the remaining peice.Additional information received states "while patient was in our care, after incident, no acute condition signs or symptoms could be attributed to the metal.".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "piece of needle broke off in patient wrist".The patient was transferred 24 hours after the event and will no consultation for the remaining piece.Additional information received states "while patient was in our care, after incident, no acute condition signs or symptoms could be attributed to the metal.".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "piece of needle broke off in patient wrist".The patient was transferred 24 hours after the event and will no consultation for the remaining piece.Additional information received states "while patient was in our care, after incident, no acute condition signs or symptoms could be attributed to the metal.".
Additional Manufacturer Narrative
Qn#(b)(4) corrected data: section d.1.-brand name corrected to arrow ra cath set: 22 ga x 1-3/8in section d.4.-catalog # corrected to ra-04122 section d.4.-udi# corrected to : (b)(4) complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.The instructions for use (ifu) provided with this kit informs the user , "warning: to reduce the risk of guidewire damage, do not retract guidewire against edge of needle while in vessel.Precaution: do not reinsert needle into catheter; doing so may result in patient injury or catheter damage." without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW RA CATH SET: 22 GA X 1-3/8IN
• Common Device Name: WIRE GUIDE CATHETER
• 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: 24257462
• Report Number: 9680794-2026-00065
• Device Sequence Number: 8327177
• Product Code: DQX
• UDI-Device Identifier: 00801902002754
• UDI-Public: (01)00801902002754(11)241020(17)290930(10)14F24K0372(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K810675
• 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,Followup
• Report Date (Section B): 01/09/2026

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: RA-04122
• Device Lot Number: 14F24K0372
• 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: 01/09/2026
• Supplement Date Received by Manufacturer: 02/27/2026; 07/07/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 03/05/2026; 07/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2024
• 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