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

Model Number	IPN920760
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	07/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
There was a problem advancing the catheter in the epidural space.Device was changed.Sensation of resistance again, then suddenly the catheter advanced, creating a breach / puncture in the dura mater.Consequence: new epidural catheter inserted and blood patch applied on 47 hours.
Additional Manufacturer Narrative
(b)(4).The customer reported the catheter was difficult to advance.The customer returned one opened kit.The epidural needle and epidural catheter were removed and visually examined with and without magnification.Visual examination of returned needle and catheter revealed both components appear typical with no defects or anomalies observed.A dimensional inspection was performed on the returned epidural needle.The inner diameter measured 0.047in (1.194mm), which is within specification range of 1.19-1.22mm per graphic.A dimensional inspection was performed on the returned epidural catheter.The outer diameter of the returned catheter measured 1.03mm, 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 no resistance met.A drag test was performed using the returned components and a weight.The catheter could thread through the returned needle with no resistance met.The components passed the drag test.A device history record review was performed on the epidural needle and epidural catheter with no relevant findings.A design history review was performed for part #rz-05400-006, kz-05400-002, and kz-05400-030 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.The reported complaint of the catheter being difficult to advance could not be confirmed based on the sample received.The returned catheter could be threaded through the returned needle with no resistance met.The returned components passed a functional drag test, and the returned needle id and returned catheter outer diameter were found to be within specification.A device history record review was performed on the epidural needle and epidural catheter with no relevant findings.Therefore, based on the condition of the sample received, there were no functional issues found with the returned sample.No further action is required at this time.
Event or Problem Description
There was a problem advancing the catheter in the epidural space.Device was changed.Sensation of resistance again, then suddenly the catheter advanced, creating a breach / puncture in the dura mater.Consequence: new epidural catheter inserted and blood patch applied on 47 hours.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20040940
• Report Number: 3006425876-2024-00824
• Device Sequence Number: 20832585
• Product Code: BSO
• UDI-Device Identifier: 40801902029674
• UDI-Public: (01)40801902029674(11)231220(17)251130(10)71F23M0724(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K140110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2025
• Device Model Number: IPN920760
• Device Catalogue Number: JC-05400-B
• Device Lot Number: 71F23M0724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2023
• 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: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown