MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION CATHETER

Model Number IPN045607

Device Problems Difficult to Remove (1528); Separation Problem (4043)

Patient Problem Pain (1994)

Event Date 12/04/2021

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

Incident happened late on a saturday night shift and the doctor was made aware at a later date and was tasked with handling the complaint.Nurses pull epidurals out in ob and during removal the epidural catheter was broken, and the tip remains in the patient.The tip is still in the patient and x-ray shows the wire is out.A decision has not been made as whether to remove or leave the tip in.Patient was complaining about pain in her back after finding out but, is otherwise stable.Refresher training is going to be scheduled with arrow representative and nursing staff for epidural removal.

Event Description

Incident happened late on a saturday night shift and the doctor was made aware at a later date and was tasked with handling the complaint.Nurses pull epidurals out in ob and during removal the epidural catheter was broken , and the tip remains in the patient.The tip is still in the patient and x-ray shows the wire is out.A decision has not been made as whether to remove or leave the tip in.Patient was complaining about pain in her back after finding out but is otherwise stable.Refresher training is going to be scheduled with arrow representative and nursing staff for epidural removal.

Manufacturer Narrative

(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.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 without the actual 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.Therefore, the potential cause of this complaint could not be determined based upon the information provided and without a sample.No further action is required at this time.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• 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: 12984399
• MDR Text Key: 282267897
• Report Number: 1036844-2021-00182
• Device Sequence Number: 1
• Product Code: BSO
• UDI-Device Identifier: 60801902005139
• UDI-Public: 60801902005139
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: IPN045607
• Device Catalogue Number: AK-05502
• Device Lot Number: 23F21H0039
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/10/2021
• Initial Date FDA Received: 12/13/2021
• Supplement Dates Manufacturer Received: 01/24/2022
• Supplement Dates FDA Received: 01/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Female