MAUDE Adverse Event Report: TELEFLEX MEDICAL EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION KIT

Catalog Number HS-05501

Device Problems Material Separation (1562); Uncoiled (1659)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/27/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The catheter was placed by one physician, and the catheter was placed with no issues on the first pass.This patient had some scoliosis, but was not a major issue.Upon removal, there was some resistance and the inner spring wound coil started to unravel and the end of the catheter separated.The tip of the catheter remained in the patient, but all of the inner spring came out of the patient.3.2 mm of the catheter end remained in the patient, but they were still uncertain if they would remove it or not as it was outside of the epidural space.The patient's condition is unknown at this time.

Manufacturer Narrative

(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.However, the customer did return a photo that clearly shows a catheter that looks to be stretched (reference files pic_tc# 1900051950).The ifu for this kit, e-17019-100d; rev.03, was reviewed as a part of this complaint investigation.The ifu warns the end user, "never advance the catheter more than 5 cm.Advancing the catheter more than 5 cm increases the likelihood of the catheter tip being placed into the anterolateral portion of the epidural space and increases the potential for the catheter knotting." the ifu 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.During epidural catheter removal, the literature indicates a force of approximately 1/3 of a pound is all that is necessary to exert if patient is other remarks: properly positioned in the recommended lateral neutral position." 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.However , the reported complaint of the catheter breaking during removal was confirmed based on a photo received from the customer.A device history record review was performed on the epidural needle with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of the catheter being difficult to remove and breaking could not be determined based upon the information provided and without a sample.

Event Description

The catheter was placed by one physician, and the catheter was placed with no issues on the first pass.This patient had some scoliosis, but was not a major issue.Upon removal, there was some resistance and the inner spring wound coil started to unravel and the end of the catheter separated.The tip of the catheter remained in the patient, but all of the inner spring came out of the patient.3.2 mm of the catheter end remained in the patient, but they were still uncertain if they would remove it or not as it was outside of the epidural space.The patient's condition is unknown at this time.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 6519073
• MDR Text Key: 73616872
• Report Number: 1036844-2017-00161
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: HS-05501
• Device Lot Number: 23F17A0560
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2017
• 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