MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW STIMUCATH SET: 20G CSTH, 18G X 8CM NDL; ANESTHESIA CONDUCT KIT

Catalog Number	AB-20608-S
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that: "the catheter has been torn when being withdrawn through the needle.It was removed in its entirety, no pieces remained in the patient.No harm occurred.The patient did have to undergo a second procedure to place a new catheter.".
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the epidural catheter and stimulating needle with no evidence to indicate a manufacturing related issue.The customer did provide a photo that appears to show a damaged epidural catheter running through a stimulating needle.However, the potential cause of this complaint could not be determined based upon the information provided and without a sample.No further action is required at this time.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "the catheter has been torn when being withdrawn through the needle.It was removed in its entirety, no pieces remained in the patient.No harm occurred.The patient did have to undergo a second procedure to place a new catheter.".

• Brand Name: ARROW STIMUCATH SET: 20G CSTH, 18G X 8CM NDL
• Common Device Name: ANESTHESIA CONDUCT KIT
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22640791
• Report Number: 9680794-2025-00631
• Device Sequence Number: 5418973
• Product Code: CAZ
• UDI-Device Identifier: 20801902126072
• UDI-Public: (01)20801902126072(11)250211(17)270131(10)14F25A0328(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K030937
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: AB-20608-S
• Device Lot Number: 14F25A0328
• 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: 07/03/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 08/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2025
• 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