MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW EPIDURAL CATHETER KIT: 19 GA X 90 CM; ANESTHESIA CONDUCTION CATHETER

Catalog Number	ASK-05503-UPM1
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "one of the crnas attempted an epidural placement last night and the needle broke off of the hub.There was not anything atypical from the insertion or complications otherwise.No medical intervention was performed due to the alleged product issue.".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4) the reported complaint of the breaking off from the hub was confirmed based on the sample received.The customer returned one injection needle, one epidural needle, and lidstock.Visual examination of the returned sample revealed the epidural needle's cannula was detached from the needle's hub.A device history record review was not required as a part of this complaint investigation.Based on the condition of the sample received, the potential root cause of this complaint issue is supplier related.Further actions were initiated under the teleflex quality system to evaluate this issue.
Event or Problem Description
It was reported that: "one of the crnas attempted an epidural placement last night and the needle broke off of the hub.There was not anything atypical from the insertion or complications otherwise.No medical intervention was performed due to the alleged product issue.".

• Brand Name: ARROW EPIDURAL CATHETER KIT: 19 GA X 90 CM
• Common Device Name: ANESTHESIA CONDUCTION 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 22211979
• Report Number: 9680794-2025-00485
• Device Sequence Number: 18179849
• Product Code: BSO
• UDI-Device Identifier: 40801902056298
• UDI-Public: (01)40801902056298(11)241212(17)260430(10)33F24L0549(21)
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K140110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2025

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 Expiration Date: 04/30/2026
• Device Catalogue Number: ASK-05503-UPM1
• Device Lot Number: 33F24L0549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2025
• Supplement Date Received by Manufacturer: 07/02/2025
• Initial Report FDA Received Date: 06/16/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/12/2024
• 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