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

Catalog Number	AK-05503-L
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "the catheter was catching when exiting the epidural needle.Got kinked as well." the patient had to be intubated for the procedure.No patient harm or injury.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "the catheter was catching when exiting the epidural needle.Got kinked as well." the patient had to be intubated for the procedure.No patient harm or injury.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer reported the catheter was kinking during use.The customer returned one opened kit.The epidural needle and epidural catheter were removed and were visually examined with and without magnification.Visual examination of the returned needle revealed the needle appears typical with no defects or anomalies observed.Visual examination of the returned catheter revealed the catheter appears used.Biological material can be seen between the inner coils.No other defects or anomalies were observed.A dimensional inspection was performed on the returned epidural needle.The inner diameter measured 0.048in, which is within specification of a minimum of 0.0460in per graphic.A dimensional inspection was performed on the returned epidural catheter.The outer diameter of the returned catheter measured 1.06mm, which is within the specification of a maximum of 1.115mm per graphic.A functional test was performed on the returned sample by attempting to thread the returned catheter through the returned epidural needle.The catheter was threaded at the distal end and would thread through the epidural needle with some resistance met, which caused the catheter to kink at a certain point.A drag test was performed using the returned components and a weight.The catheter could thread through the returned needle; however, with a considerable amount of resistance met.The components failed the drag test.The drag test was repeated using the returned catheter and a lab inventory epidural needle.The returned catheter could thread through the lab inventory needle with no resistance met.The components passed the drag test, indicating there was no issue with the returned epidural catheter.The drag test was once again repeated using a lab inventory epidural catheter and the returned epidural needle.The lab inventory catheter could thread through the returned needle; however, with a considerable amount of resistance met.The components failed the drag test, indicating there was an issue with the returned epidural needle.A device history record review was performed on the epidural catheter and epidural needle with no relevant findings.The reported complaint of the catheter kinking during use was partially confirmed based on the sample received.The returned catheter could be threaded through the returned needle; however, with some resistance met causing the returned catheter to kink.The returned components failed a functional drag test.The returned catheter could be threaded through a lab inventory epidural needle with no resistance met and passed a functional drag test, indicating there was an issue with the returned epidural needle and not the returned epidural catheter.Also, the returned catheter outer diameter was found to be within specification.A device history record review was performed on the epidural catheter and epidural needle with no relevant findings.Therefore, based on the functional testing performed on the returned catheter with a lab inventory needle, there were no functional issues found with the returned sample.

• Brand Name: ARROW EPIDURAL CATHETERIZATION KIT
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19352979
• Report Number: 9680794-2024-00479
• Device Sequence Number: 7232320
• Product Code: BSO
• UDI-Device Identifier: 70801902005150
• UDI-Public: 70801902005150
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2024

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 Expiration Date: 04/30/2025
• Device Catalogue Number: AK-05503-L
• Device Lot Number: 33F23K0626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2024
• Supplement Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 05/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/25/2023
• 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: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown