MAUDE Adverse Event Report: TELEFLEX ARRIW; EPIDURAL CATHETER

Model Number SJ-05501

Device Problems Break (1069); Crack (1135)

Patient Problem Discomfort (2330)

Event Date 04/12/2020

Event Type  malfunction  

Event Description

Epidural inserted at 0900, pt comfortable.At 1530 pt uncomfortable, epidural bolus planned.When filter disconnected to administer bolus, crack noticed and filter proceeded to break apart.Epidural removed and new catheter inserted.

• Brand Name: ARRIW
• Type of Device: EPIDURAL CATHETER
• Manufacturer (Section D): TELEFLEX; reading PA
• MDR Report Key: 10004487
• MDR Text Key: 190476954
• Report Number: 10004487
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 04/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• 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: SJ-05501
• Device Lot Number: 23F20A0071
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/12/2020
• Device Age: 1 YR
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 29 YR
• Patient Weight: 77