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

Model Number	IPN046311
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.
Event or Problem Description
Several kits faced an issue.Anesthetists have great difficulty advancing the catheter once the needle is in place.Several catheters could not be inserted and others needed additional force during insertion.
Event or Problem Description
Several kits faced an issue.Anesthetists have great difficulty advancing the catheter once the needle is in place.Several catheters could not be inserted and others needed additional force during insertion.
Additional Manufacturer Narrative
(b)(4).A device history record review was performed on the epidural catheter and epidural needle with no relevant findings.The customer reported difficulty advancing the catheter into the patient.The customer returned one opened kit.The epidural catheter was removed.No epidural needle was returned.The returned catheter was visually examined with and without magnification.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 catheter.The outer diameter (od) of the returned catheter measured 1.05mm (caliper: (b)(4)) which is within the specification of a maximum of 1.115mm per graphic kz-05400-030; rev 5.A functional test was performed by attempting to thread the returned catheter through a lab inventory epidural needle.The catheter was threaded at the distal end and would thread through the epidural needle with no resistance met.A drag test was performed per pip-013; rev 5 using the returned catheter, a lab inventory needle, and a weight (ref-002579).The returned catheter could thread through the lab inventory needle with no resistance met.The returned catheter and lab inventory needle passed the drag test.Specifications per graphic kz-05400-030; rev 5 was reviewed as a part of this complaint investigation.A design history review was performed for part # kz-05400-030 and rz-05400-006 as a part of this complaint investigation.There have been no material changes for these parts during the last two years that could have led to this complaint.A corrective action is not required at this time as the root cause for this complaint investigation could not be determined based upon the information provided and the sample received.The reported complaint of difficulty advancing the catheter into the patient could not be confirmed based on the sample received.The customer returned one epidural catheter.However, the epidural needle was not returned.The returned catheter could be threaded through a lab inventory needle with no resistance met.The returned catheter passed a functional drag test, and the returned catheter od was found to be within specification.A device history record review was performed on the epidural catheter and epidural needed with no relevant findings.However, this complaint investigation could not be determined based upon the information provided and the sample received.No further action is required at this time.

• Brand Name: EPIDURAL CATHETERIZATION SET
• Common Device Name: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 14606494
• Report Number: 3006425876-2022-00537
• Device Sequence Number: 5367099
• Product Code: BSO
• UDI-Device Identifier: 00801902029676
• UDI-Public: 00801902029676
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2022

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: 12/31/2023
• Device Model Number: IPN046311
• Device Catalogue Number: JC-05400-B
• Device Lot Number: 71F22A2313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2022
• Supplement Date Received by Manufacturer: 07/13/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 07/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2022
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown