MAUDE Adverse Event Report: ARROW INTERNATIONAL INC EPIDURAL CATHETERIZATION KIT WITH FLEXTIP PLUS CATHETER AND NEEDLE; EPIDURAL ANESTHESIA KIT

Catalog Number SJ-05501

Device Problem Material Separation (1562)

Patient Problem No Information (3190)

Event Date 10/05/2015

Event Type  malfunction  

Event Description

Anesthesia connected catheter to patient.Nurse came and checked in on patient and noticed the catheter has separated.Catheter was replaced.The catheter in normal operation should click into place.It looks like this device when it clicks into place, it separates causing the epidural catheter to separate.

• Brand Name: EPIDURAL CATHETERIZATION KIT WITH FLEXTIP PLUS CATHETER AND NEEDLE
• Type of Device: EPIDURAL ANESTHESIA KIT
• Manufacturer (Section D): ARROW INTERNATIONAL INC; 2400 bernville road; reading PA 19605
• MDR Report Key: 5433387
• MDR Text Key: 38097100
• Report Number: 5433387
• 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: Other
• Type of Report: Initial
• Report Date: 02/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: SJ-05501
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/05/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 02/05/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1