MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. FLEXTIP PLUS; ANESTHESIA CONDUCTION KIT

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2015

Event Type  malfunction  

Event Description

During insertion of epidurals, the epidural space was identified with loss of resistance technique using normal saline; the obturator was removed, however, we were then unable to pass arrow catheter into the epidural space.A different catheter not in the kit is used and passes without difficulty.This has happened multiple times to a variety of anesthetists and physicians over the last 3-4 months.They feel the separate catheter has more flexibility than the catheter contained in the kit.No patient harm during any of the insertions; working with the vendor.Manufacturer response for epidural catheter kit, arrow epidural catheter kit (per site reporter): vendor working with us, gave us other catheters to use; took our info and experience back to their research and development team.

• Brand Name: FLEXTIP PLUS
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL, INC.; 2400 bernville road; reading PA 19605
• MDR Report Key: 5027481
• MDR Text Key: 23947220
• Report Number: 5027481
• 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
• Report Date: 07/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/07/2015
• Event Location: Hospital
• Date Report to Manufacturer: 07/07/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1