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

Model Number IPN040138

Device Problem No Flow (2991)

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

Event Date 03/15/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

During clinical status, the customer found the liquid medicine could not be injected into the catheter.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The customer reported medication would not inject into the catheter.The customer returned one snaplock assembly, one epidural catheter w/stylet, and lidstock.The returned components were visually examined with and without magnification.Visual examination of the returned snaplock assembly revealed the snaplock appears typical with no observed defects or anomalies.Visual examination of the returned catheter revealed the catheter appears to have been cut at the distal end.Also, the proximal end is still intact, but the coil wire is slightly damaged.No other defects or anomalies were observed.A dimensional inspection was performed on the returned catheter using a ruler (10171599).The returned catheter measures approximately 64.5 cm.This indicates at least 25.5 cm of the catheter is missing as the specification for the epidural catheter, indicates the proper catheter length is 90.0-90.8 cm per graphic c-05000-012; rev.3.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 (ref-002902) and the pressure was increased to 10 psi to establish flow.Water could be seen immediately exiting the likely distal end of the catheter.Specifications per graphic c-05000-012; rev.3 were reviewed as a part of this complaint investigation.The ifu for this kit, e-17019-110a; rev.2, was reviewed as a part of this complaint investigation.The ifu cautions the user, "do not alter the catheter or any other kit/set component during insertion, use or removal (except as instructed)." a corrective action is not required at this time as the root cause for this complaint investigation could not be determined based upon the information provided and the condition of the sample received.The reported complaint of the medication not being able to inject through the catheter could not be confirmed based on the sample re ceived.The customer returned a snaplock assembly and epidural catheter.Approximately 25.5cm of the returned catheter was missing from the distal end of the catheter.The catheter appears to have been cut.The returned snaplock assembly and catheter did pass a functional flow test.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related issue.Therefore, based on this, this complaint investigation could not be determined based upon the information provided and the condition of the sample received.

Event Description

During clinical status, the customer found the liquid medicine could not be injected into the catheter.

• Brand Name: EPIDURAL CATHETERIZATION COMPONENT
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 11665515
• MDR Text Key: 245392853
• Report Number: 1036844-2021-00070
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00801902009746
• UDI-Public: 00801902009746
• Combination Product (y/n): N
• PMA/PMN Number: K801912
• 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: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: IPN040138
• Device Catalogue Number: EC-05000
• Device Lot Number: 13F19L0478
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2021
• Date Manufacturer Received: 05/07/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/25/2019
• 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
• Treatment: N/A.