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

Catalog Number ASK-05501-GH

Device Problems Break (1069); Positioning Failure (1158); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/19/2024

Event Type  Injury  

Event Description

It was reported that prior to use "while anesthesiologist was trying to pull the catheter back to a depth that was wanted, the catheter broke".As a result, the catheter was surgically removed.The entire catheter was able to be removed, no fragments were left in the patient.No patient harm or injury.The current status of the patient is reported as "stable, discharged home".

Manufacturer Narrative

Qn#(b)(4).N/a other remarks: n/a corrected data: n/a.

Event Description

It was reported that prior to use "while anesthesiologist was trying to pull the catheter back to a depth that was wanted, the catheter broke".As a result, the catheter was surgically removed.The entire catheter was able to be removed, no fragments were left in the patient.No patient harm or injury.The current status of the patient is reported as "stable, discharged home.".

Manufacturer Narrative

Qn# (b)(4), voluntary report# mw5152014.Visual inspection could not be performed as no sample was returned for analysis.The customer did provide a photo that appears to show an epidural catheter and snaplock assembly.A device history record review was performed on the epidural catheter with no relevant findings.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a, corrected data: n/a.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18820328
• MDR Text Key: 336733121
• Report Number: 3004365956-2024-00012
• Device Sequence Number: 1
• Product Code: BSO
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/20/2024

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: 04/01/2024
• Device Catalogue Number: ASK-05501-GH
• Device Lot Number: 37F22J0008
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/01/2024
• Supplement Dates Manufacturer Received: 04/08/2024
• Supplement Dates FDA Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1