MAUDE Adverse Event Report: TELEFLEX ARROW FLEXTIP PLUS EPIDURAL CATHETER

Device Problems Break (1069); Detachment Of Device Component (1104); Physical Resistance (2578)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/07/2017

Event Type  Injury  

Event Description

During removal of the epidural catheter, resistance was felt and approximately 3 inches of the catheter broke off.This was retained within the epidural space.

• Brand Name: ARROW FLEXTIP PLUS EPIDURAL CATHETER
• Type of Device: EPIDURAL CATHETER
• Manufacturer (Section D): TELEFLEX; wayne PA 19087
• MDR Report Key: 7027554
• MDR Text Key: 91936466
• Report Number: MW5073303
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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 Outcome(s): Other
• Patient Age: 83 YR
• Patient Weight: 122