MAUDE Adverse Event Report: TELEFLEX INCORPORATED FLEXTIP PLUS(R) EPIDURAL CATHETERIZATION KIT; CATHETER, CONDUCTION, ANESTHETIC

Model Number IPN045729

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 02/26/2021

Event Type  malfunction  

Event Description

Epidural catheter leaking approximately 2.3 cm from "snap-lock" catheter/syringe adapter after patient was bolused and epidural pump running.Epidural disconnected and replaced with new epidural catheter.Manufacturer response for epidural catheter, teleflex flex-tip plus (per site reporter).Teleflex recommends checking the integrity of the epidural catheter before insertion.

• Brand Name: FLEXTIP PLUS(R) EPIDURAL CATHETERIZATION KIT
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): TELEFLEX INCORPORATED; po box 12600; durham NC 27709
• MDR Report Key: 11504221
• MDR Text Key: 240333000
• Report Number: 11504221
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/09/2021

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 Model Number: IPN045729
• Device Catalogue Number: ASK-17019-SM
• Device Lot Number: 23F20K0162
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/09/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 7300 DA
• Patient Weight: 59