MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. ARROW INTERNATIONAL EPIDURAL CATHETER; TRAY EPIDURAL FLEXTIP PLUS 19 GA

Model Number SJ-05501

Device Problem Component Missing (2306)

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

Event Date 07/03/2017

Event Type  malfunction  

Event Description

Labor epidural catheter removed by staff.Upon removal noted that black tip of catheter was missing.Catheter removal was not difficult per staff interview.Ct scan was completed.After literature review and physician consults it was determined that removal of the catheter tip was not indicated.Patient would be monitored for signs of infection as well as neuro symptoms.Patient remained asymptomatic and had a normal post partum period.

• Brand Name: ARROW INTERNATIONAL EPIDURAL CATHETER
• Type of Device: TRAY EPIDURAL FLEXTIP PLUS 19 GA
• Manufacturer (Section D): ARROW INTERNATIONAL, INC. ; reading PA 19605
• MDR Report Key: 6872033
• MDR Text Key: 86563102
• Report Number: MW5072187
• 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: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SJ-05501
• Device Catalogue Number: SJ-5501
• 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 Age: 22 YR
• Patient Weight: 78