MAUDE Adverse Event Report: TELEFLEX MEDICAL ARROW EPIDURAL CATHERIZATION KIT; ANESTHESIA CONDUCTION KIT

Model Number REF AK05502

Device Problem Disconnection (1171)

Patient Problem No Information (3190)

Event Date 10/21/2015

Event Type  malfunction  

Event Description

Patient status post colectomy for diverticulitis.Epidural given for postop pain control.Rn entered room and found epidural tubing disconnected and lying on floor.Epidural site intact, but wire was unattached from tubing.

• Brand Name: ARROW EPIDURAL CATHERIZATION KIT
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): TELEFLEX MEDICAL; 2400 bernville road; reading PA 19605
• MDR Report Key: 5249713
• MDR Text Key: 32146069
• Report Number: 5249713
• 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: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: REF AK05502
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/16/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 11/16/2015
• 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
• Treatment: OTHER, UNKNOWN AT THIS TIME
• Patient Age: 76 YR