MAUDE Adverse Event Report: EPIDURAL CATHETERIZATION KIT

Catalog Number TI-05501-ME

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/01/2020

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: about my call with the doctor from (b)(6) hospital, they have a concern regarding the epidural catheter which cut during withdrawal the catheter from the patient.They asked if there is any update has been applied on the catheter causing this accident.Also, they are asking about a comparison between b.Brun catheter, protex catheter and arrow catheter.Additional information: patient has been discharged to home with catheter piece left in the body.The device was no tested prior to use.No medical intervention was performed.The device is not available for investigation.About 7cm of the epidural catheter broke including its tip.It was left in the patient because it was broken while pulling out.(no symptoms and neurological team decided to leave it and follow up with her as she is recovering from other procedure.The procedure was labor analgesia.

Event Description

Reported issue: about my call with the doctor from kfsh hospital, they have a concern regarding the epidural catheter which cut during withdrawal the catheter from the patient.They asked if there is any update has been applied on the catheter causing this accident.Also, they are asking about a comparison between b.Brun catheter, protex catheter and arrow catheter.Additional information: patient has been discharged to home with catheter piece left in the body.The device was no tested prior to use.No medical intervention was performed.The device is not available for investigation.About 7cm of the epidural catheter broke including its tip.It was left in the patient because it was broken while pulling out.(no symptoms and neurological team decided to leave it and follow up with her as she is recovering from other procedure.The procedure was labor analgesia.

Manufacturer Narrative

Qn# (b)(4).A device history record review was performed on the epidural catheter with no relevant findings.Visual inspection could not be performed as no sample was returned by the customer for investigation.The customer did provide a photo that appears to show a broken catheter piece.The ifu for this kit, e-17019-110a; rev.02, was reviewed as a part of this complaint investigation.The ifu warns the end user, "never advance catheter more than 5 cm beyond the needle tip.Advancing catheter more than 5 cm increases the likelihood of catheter-related complications." the ifu also warns the user, "never tug or quickly pull on catheter during removal from patient to reduce risk of catheter breakage.Do not apply additional tension on the catheter if catheter begins to stretch excessively.Reposition patient to open the vertebral interspaces and re-attempt removal if resistance is encountered or if catheter stretches excessively during removal." a corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the epidural catheter with no relevant findings.The customer did provide photos that appear to show a broken catheter.However, without the actual sample, the potential cause of this complaint could not be determined based upon the information provided.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• MDR Report Key: 10763650
• MDR Text Key: 224590921
• Report Number: 3006425876-2020-00961
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• 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: 10/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2022
• Device Catalogue Number: TI-05501-ME
• Device Lot Number: 71F20C0181
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2020
• 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