MAUDE Adverse Event Report: TELEFLEX FLEX TIP PLUS EPIDURAL CATHETER; ARROW EPIDURAL CATHETER

Device Problem Human-Device Interface Problem (2949)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/29/2022

Event Type  Injury  

Event Description

During removal of a flex tip plus epidural catheter the catheter broke and retracted leaving a portion of the catheter retained in the patient.The patient did require a surgical procedure to remove the retained portion of the epidural catheter.Pt was discharged home a day after the surgical procedure.Pt was discharged home a day after the surgical procedure.

• Brand Name: FLEX TIP PLUS EPIDURAL CATHETER
• Type of Device: ARROW EPIDURAL CATHETER
• Manufacturer (Section D): TELEFLEX; morrisville NC
• MDR Report Key: 16024107
• MDR Text Key: 305919363
• Report Number: 16024107
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/06/2022,12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/29/2022
• Event Location: Hospital
• Date Report to Manufacturer: 12/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 25 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White