MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC (SUBSIDIARY OF TELEFLEX INCORPORATED) FLEXTIP PLUS EPIDURAL CATHETERIZATION KIT; CATHETER, CONDUCTION, ANESTHETIC

Model Number ASK-05401-PVH

Device Problem Flushing Problem (1252)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/16/2021

Event Type  malfunction  

Event Description

Patient received an epidural and the anesthesia provider was unable to flush the epidural catheter once it was placed in the patients epidural space.When the catheter was flushed the flush fluid, the fluid exited from the hub that the syringe was attached to.The epidural catheter was pulled and the patient was prepped and draped for a second placement.Fda safety report id # (b)(4).

• Brand Name: FLEXTIP PLUS EPIDURAL CATHETERIZATION KIT
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): ARROW INTERNATIONAL LLC (SUBSIDIARY OF TELEFLEX INCORPORATED)
• MDR Report Key: 12032146
• MDR Text Key: 257423462
• Report Number: MW5101970
• Device Sequence Number: 1
• Product Code: BSO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/15/2021

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: 05/31/2021
• Device Model Number: ASK-05401-PVH
• Device Lot Number: 23F19M0295
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/17/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 35 YR