MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION KIT

Model Number 19 GA X 90 CM

Device Problem Flushing Problem (1252)

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

Event Date 06/10/2016

Event Type  malfunction  

Event Description

The anesthesiologist was unable to inject fluid into the epidural catheter after insertion.The catheter was then removed and a second catheter was inserted.The md was then able to easily inject fluid, and complete the procedure with no complications.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): ARROW INTERNATIONAL, INC.; 312 commerce place; asheboro NC 27203
• MDR Report Key: 5778347
• MDR Text Key: 49091971
• Report Number: 5778347
• 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: 06/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 08/31/2017
• Device Model Number: 19 GA X 90 CM
• Device Catalogue Number: ASK-05400-SM
• Device Lot Number: 23F16C0469
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/21/2016
• Event Location: Hospital
• Date Report to Manufacturer: 06/21/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 122