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

Catalog Number	AK-05501
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "catheter leaked while administering drugs for adductor canal block.There was no reported patient harm or con sequence.".
Additional Manufacturer Narrative
Qn# (b)(4).The customer reported the catheter was leaking.The customer returned an epidural catheter and lidstock.The returned sample was visually examined with and without magnification.Visual examination of the returned catheter revealed that the catheter appears used as biological material can be seen between the inner coils.No other defects or anomalies were observed.Dimensional inspection was not required as a part of this complaint investigation.Functional inspection was performed on the returned sample.A functional leak test was performed, using the returned catheter and a lab inventory snaplock assembly with the lab leak tester.The proximal end of the catheter was inserted into the snaplock assembly until it bottomed out and the components were locked.The catheter was confirmed to be secured by tugging gently.The snaplock assembly was then connected to the lab leak tester and the pressure was increased to 10 psi to establish flow.The distal end of the catheter was then capped off and the pressure was increased to 25 psi for 30 seconds.No leak was detected and therefore, no functional issues were found with the returned sample.A device history record review was performed on the epidural catheter with no relevant findings.The reported complaint of the catheter leaking could not be confirmed based on the sample received.The returned catheter was functionally leak tested with no leaks observed.A device history record review was performed on the epidural catheter with no relevant findings.Therefore, based on the functional testing, there were no issues found with the returned sample.No further action is required at this time.
Event or Problem Description
It was reported that: "catheter leaked while administering drugs for adductor canal block.There was no reported patient harm or con sequence.".

• Brand Name: ARROW EPIDURAL CATHETERIZATION KIT: 19 GA
• 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: sachin sony ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21409436
• Report Number: 9680794-2025-00146
• Device Sequence Number: 8214427
• Product Code: BSO
• UDI-Device Identifier: 40801902005128
• UDI-Public: (01)40801902005128(11)240609(17)260430(10)33F24E0057(21)
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 01/30/2025

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: AK-05501
• Device Lot Number: 33F24E0057
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2024
• 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