MAUDE Adverse Event Report: TELEFLEX MEDICAL ARROW® EPIDURAL CATHETERIZATION KIT WITH FLEXTIP PLUS® CATHETER; ANESTHESIA CONDUCTION KIT

Model Number ASK-05502-MGH

Device Problems Fracture (1260); Leak/Splash (1354)

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

Event Date 02/15/2017

Event Type  malfunction  

Event Description

Fractured epidural catheter: mds saw the patient on post operative day 2 and noted the epidural was leaking at the insertion site.They removed it and noted that the plastic catheter was fractured but did not sever because of the metal coil that encases the epidural tube.No portion of the catheter was retained.It is unclear when the catheter fractured during use.

• Brand Name: ARROW® EPIDURAL CATHETERIZATION KIT WITH FLEXTIP PLUS® CATHETER
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section D): TELEFLEX MEDICAL; 3015 carrington mill blvd.; morrisville NC 27560
• MDR Report Key: 6463459
• MDR Text Key: 71879772
• Report Number: 6463459
• 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: 03/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: ASK-05502-MGH
• Device Catalogue Number: ASK-05502-MGH
• Device Lot Number: 23F16H1048
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/22/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/22/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/06/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 77