MAUDE Adverse Event Report: TELEFLEX ARROW EPIDURAL

Lot Number 23F21J0015

Device Problem Disconnection (1171)

Patient Problem Pain (1994)

Event Date 12/04/2021

Event Type  malfunction  

Event Description

Pt for induction of labor.Epidural placed at 1330.At 2200 patient stated she could feel pain.Nursing assessment found the patient's epidural catheter had become disconnected from the tubing requiring a new epidural be replaced.

• Brand Name: ARROW EPIDURAL
• Type of Device: ARROW
• Manufacturer (Section D): TELEFLEX; morrisville NC 27560
• MDR Report Key: 13059537
• MDR Text Key: 282786173
• Report Number: 13059537
• 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: 12/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 23F21J0015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/06/2021
• Distributor Facility Aware Date: 12/06/2021
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 20 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White