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

Catalog Number ASK-05400-SM

Device Problem Packaging Problem (3007)

Patient Problem No Information (3190)

Event Date 07/01/2016

Event Type  malfunction  

Event Description

Patient was to undergo a thoracic epidural procedure.However, upon opening the epidural tray, it was discovered that the saline vial was already open.

• Brand Name: FLEXTIP PLUS
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL, INC.; 11245 n. distribution cove; olive branch MS 38654
• MDR Report Key: 6053938
• MDR Text Key: 58294885
• Report Number: 6053938
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/02/2016,08/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: ASK-05400-SM
• Device Lot Number: 23F16D0378
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/02/2016
• Event Location: Hospital
• Date Report to Manufacturer: 08/02/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 99