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

Catalog Number JC-05400-B

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event Description

It was reported that during insertion, the medical staff noticed the end of the catheter was blocked.

Manufacturer Narrative

(b)(4).The batch numbers from nuevo laredo components related with the batch 71f18h1863 are the following: 74c1801333 (ca-000010-19),74d1802051(ca-000010-19), 74d1801888 (ca-000006-19), 74c1801849 (ca-000006-19), 74d1801887 (ca-000006-19).No relevant findings were found during the dhr review of these batch.Such batch were manufactured on march and april of 2018.A sample of catalog number ca-000010-19 (snaplock assy) was received for analysis.The visual inspection was performed before the functional test and it cannot appreciated the orifice where the catheter is introduced.After functional test the sample was broken and visually inspected again and was found the soft tube ca-000006-19 bent near to catheter insertion component tfx-000414.Sample received was compared with current production.The sample fail the catheter insertion test (wi-002685 rev.03) equipment nlc08827 neither the leak and occlusion test (tp-000031 rev.02) equipment nlc09272.A non-conformance was opened in order to address snaplock occluded.Some corrective actions were performed.Re-work 100 % of current material wi-002292 was updated with the correct assembly the soft tube and correct way to perform the test tp-00031.Visual aid va-0335 was created to show the correct assembly of soft tube.Personnel was re-trained on those changes material is inspected 100% for occlusion.Customer complaint is confirmed based on the visual inspection.However, a non-conformance was opened in order to address snaplock occluded.Some corrective actions were performed on september 2018.

Event Description

It was reported that during insertion, the medical staff noticed the end of the catheter was blocked.

• Brand Name: EPIDURAL CATHETERIZATION SET
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 8070832
• MDR Text Key: 127215880
• Report Number: 3006425876-2018-00727
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• PMA/PMN Number: K140110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2020
• Device Catalogue Number: JC-05400-B
• Device Lot Number: 71F18H1863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Date Manufacturer Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1