MAUDE Adverse Event Report: EPIDURAL CATHETERIZATION SET; ANESTHESIA CONDUCTION KIT

Catalog Number JC-05400-B

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2020

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

Reported issue: involving a (b)(6) years old female patient who was going to give birth.During the insertion of the catheter performed by the anesthesia doctor it was impossible to inject the treatment through the catheter (resistance/blockage).We used a different syringe with saline water to try again; no success.We removed the catheter from 1 centimeter and then we totally removed the catheter out of the patient we tried to inject and flush the catheter, it was impossible.Clinical consequence: we needed to start the process again and perform another insertion with a new catheter with success.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The customer reported the catheter would not inject medication.The customer returned one 10ml injection syringe, one flat filter, one snaplock assembly, an epidural catheter, and lidstock.The returned components were received connected together (reference attached files inp1900080266).The returned components were visually examined with and without magnification.Visual examination of the returned filter and snaplock assembly revealed both components appear typical with no observed defects or anomalies.Visual examination of the returned catheter revealed the catheter appears used.Biological material can be seen between the inner coils.No other defects or anomalies were observed.A functional flow test was performed on the returned sample per amrq-000017 section 7.8; rev.8.The returned 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 (b)(4) 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 5.8ml/min (stopwatch: (b)(4), which is within the specification of 1ml/min minimum.No blockages were found.A corrective action is not required at this time as there were no functional issues found with the returned sample.The reported complaint of the catheter not injecting medication could not be confirmed based on the sample received.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related issue.The returned components passed a functional flow test and met flow rate specifications.There were no functional issues found with the returned sample.

Event Description

Reported issue: involving a 33 years old female patient who was going to give birth.During the insertion of the catheter performed by the anesthesia doctor it was impossible to inject the treatment through the catheter (resistance/blockage).We used a different syringe with saline water to try again; no success.We removed the catheter from 1 centimeter and then we totally removed the catheter out of the patient we tried to inject and flush the catheter, it was impossible.Clinical consequence: we needed to start the process again and perform another insertion with a new catheter with success.

• Brand Name: EPIDURAL CATHETERIZATION SET
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 10818313
• MDR Text Key: 215584765
• Report Number: 3006425876-2020-00962
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: K103658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2022
• Device Catalogue Number: JC-05400-B
• Device Lot Number: 71F20G2279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Date Manufacturer Received: 12/07/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/24/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1