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

Model Number	IPN040141
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the doctor found tube blocked when using on patient.Then changed new one, no impact on patient." at the time of this report, the customer has not returned our requests for additional information.The complaint file will be updated if further information is received.
Additional Manufacturer Narrative
Qn#(b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "the doctor found tube blocked when using on patient.Then changed new one, no impact on patient." at the time of this report, the customer has not returned our requests for additional information.The complaint file will be updated if further information is received.
Additional Manufacturer Narrative
Qn#(b)(4).The reported complaint of the catheter being blocked could not be confirmed based on the sample received.The customer returned one snaplock assembly.No epidural catheter was returned.The returned sample was visually examined with and without magnification.Visual examination of the returned snaplock assembly revealed the snaplock was received disassembled.No other defects or anomalies were observed.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related issue.Therefore, based on this, the root cause of this complaint could not be determined based upon the information provided and the sample received.No further action was required at this time.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that "the doctor found tube blocked when using on patient.Then changed new one, no impact on patient." at the time of this report, the customer has not returned our requests for additional information.The complaint file will be updated if further information is received.

• Brand Name: EPIDURAL CATHETERIZATION SET: 19 GA
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 16857135
• Report Number: 3006425876-2023-00500
• Device Sequence Number: 3276414
• Product Code: BSO
• UDI-Device Identifier: 00801902003416
• UDI-Public: 00801902003416
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K140110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/03/2023

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: 10/31/2023
• Device Model Number: IPN040141
• Device Catalogue Number: EC-05400-E
• Device Lot Number: 71F21L1640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2023
• Supplement Date Received by Manufacturer: 05/19/2023; 07/25/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 05/24/2023; 07/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/24/2021
• 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
• Patient Sex: Unknown