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

Model Number	IPN046311
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Reported event: the catheter kinked inside the snaplock which caused an occlusion; treatment flow stopped.The snaplock and the catheter were replaced.
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Additional Manufacturer Narrative
Qn# (b)(4).The actual device was not returned; however, the customer provided a photo for evaluation.The photo shows a catheter inserted into a snaplock assembly.A device history record review was performed on the epidural catheter and snaplock assembly with no relevant findings.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
Reported event: the catheter kinked inside the snaplock which caused an occlusion; treatment flow stopped.The snaplock and the catheter were replaced.

• Brand Name: ARROW 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 ; 9194332672
• MDR Report Key: 16246255
• Report Number: 3006425876-2023-00144
• Device Sequence Number: 15083771
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2023

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: 05/31/2024
• Device Model Number: IPN046311
• Device Catalogue Number: JC-05400-B
• Device Lot Number: 71F22F3609
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2023
• Supplement Date Received by Manufacturer: 03/07/2023
• Initial Report FDA Received Date: 01/26/2023
• Supplement Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED; NONE REPORTED
• Patient Sex: Unknown