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

Catalog Number AM-05501

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2016

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Complaint alleges that the patient was in labor and epidural catheter was inserted to assist with labor.At the normal interval, discontinuation of the catheter was attempted.The registered nurse met resistance while attempting to discontinue the catheter and notified the regional anesthesia provider on call.He attempted to remove the catheter but met resistance.He then flushed the catheter and again attempted to remove it.At that point, the catheter broke.The tip of the catheter was retained in the patient's l4-l5 region as confirmed by x-ray and ct.Later that day the patient was taken to the operating room for removal of the retained catheter.It was successfully removed as confirmed by x-ray.The patient was discharged two days later following confirmation that physical assessment was within normal limits.

Manufacturer Narrative

(b)(4).A device history record review could not be performed as no lot number was provided by the customer.A review of sales history data was performed to obtain a lot number.However, no record could be found.The ifu for this kit, k-05502-100d; rev.11, was reviewed as a part of this complaint investigation.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 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.Other remarks: complaint verification testing could not be performed as no sample was returned for analysis.The device history records were not reviewed as no lot number was provided by the customer and no sales history records could be found.Therefore, the potential cause of the catheter breaking could not be determined based upon the information provided and without the sample.

Event Description

Complaint alleges that the patient was in labor and epidural catheter was inserted to assist with labor.At the normal interval, discontinuation of the catheter was attempted.The registered nurse met resistance while attempting to discontinue the catheter and notified the regional anesthesia provider on call.He attempted to remove the catheter but met resistance.He then flushed the catheter and again attempted to remove it.At that point, the catheter broke.The tip of the catheter was retained in the patient's l4-l5 region as confirmed by x-ray and ct.Later that day the patient was taken to the operating room for removal of the retained catheter.It was successfully removed as confirmed by x-ray.The patient was discharged two days later following confirmation that physical assessment was within normal limits.

• 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: 5785851
• MDR Text Key: 49294141
• Report Number: 1036844-2016-00339
• 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: 06/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: AM-05501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention