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

Model Number IPN040141

Device Problem Obstruction of Flow (2423)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/28/2023

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that "the doctor found tube blocked when using on patient.Then changed new one, no impact on patient".Additional information states that the blockage was found after insertion in the snaplock.The whole device was replaced.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the snaplock assembly with a potentially relevant finding where the outer diameter for the extrusion was out of specification.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 Description

It was reported that "the doctor found tube blocked when using on patient.Then changed new one, no impact on patient".Additional i nformation states that the "blockage was found after insertion in the snaplock.The whole device was replaced".

Manufacturer Narrative

(b)(4).The reported complaint of the snaplock being blocked could not be confirmed based on the sample received.The customer returned one snaplock assembly.The returned sample was visually examined with and without magnification.Visual examination of the returned snaplock assembly revealed the snaplock appears typical with no observed defects or anomalies.A functional flow test was performed on the returned sample.A lab inventory epidural catheter was inserted from the proximal end into the returned snaplock assembly until it bottomed out and the snaplock assembly was closed.The components were confirmed to be secured by tugging gently.The snaplock assembly was connected to the lab leak tester and the pressure was increased to 10 psi to establish flow.Water could be seen immediately exiting the distal end of the catheter.The flow rate was measured at 9.0ml/min via stopwatch, which was within the specification of 1ml/min minimum.No blockages were found.A device history record review was performed on the snaplock assembly with a potentially relevant finding, which was not relevant to this complaint.Therefore, based on functional testing of the returned sample, no problem was found with the returned snaplock assembly.No further action was required at the time of the report.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a.Corrected data: n/a.

Event Description

It was reported that "the doctor found tube blocked when using on patient.Then changed new one, no impact on patient".Additional i nformation states that the "blockage was found after insertion in the snaplock.The whole device was replaced".

• Brand Name: EPIDURAL CATHETERIZATION SET: 19 GA
• Type of Device: 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: 16735036
• MDR Text Key: 313325566
• Report Number: 3006425876-2023-00430
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 00801902003416
• UDI-Public: 00801902003416
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K140110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: IPN040141
• Device Catalogue Number: EC-05400-E
• Device Lot Number: 71F21M0560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/03/2023
• Initial Date FDA Received: 04/13/2023
• Supplement Dates Manufacturer Received: 05/19/2023; 07/25/2023
• Supplement Dates FDA Received: 05/25/2023; 07/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/08/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1