MAUDE Adverse Event Report: BD EPIDURAL CATHETER; NONE

Device Problems Detachment Of Device Component (1104); Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/12/2014

Event Type  malfunction  

Event Description

Anesthesia director was preparing device for insertion.He noticed that black tip was gone.Tip found in packaging.New catheter obtained, so did not affect a specific patient.Packaging not kept, so unable to provide lot number, etc.

• Brand Name: EPIDURAL CATHETER
• Type of Device: NONE
• Manufacturer (Section D): BD
• MDR Report Key: 3835703
• MDR Text Key: 4501990
• Report Number: MW5036270
• Device Sequence Number: 1
• Product Code: CAZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1