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

Catalog Number MM-05001

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/25/2022

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).The device has not been returned for investigation.

Event Description

Received via medwatch# mw5109746.Arrow theracath epidural catheter placed on (b)(6) 2022 for pain management during brachytherapy cancer treatment, removed after treatment on (b)(6) 2022.Mri later demonstrated an incidental finding of a metallic foreign body at l5-s1 on (b)(6) 2022.Fda safety report id# (b)(4).

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.

Event Description

Received via medwatch #mw5109746.Arrow theracath epidural catheter placed on (b)(6) 2022 for pain management during brachytherapy cancer treatment, removed after tre atment on (b)(6) 2022.Mri later demonstrated an incidental finding of a metallic foreign body at l5-s1 on (b)(6) 2022.Fda safety report id# (b)(4).

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville 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: 14643287
• MDR Text Key: 301644376
• Report Number: 1036844-2022-00046
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K801912
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: MM-05001
• Device Lot Number: 13F21M0266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2021
• 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 Outcome(s): Required Intervention