MAUDE Adverse Event Report: MAQUET EDI CATHETER

Lot Number 92117646

Device Problems Infusion or Flow Problem (2964); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/19/2014

Event Type  malfunction  

Event Description

Placed new edu catheter in patient.Rt notified md that she was not able to pass anything through the catheter.The catheter was non-patent; unable to pass suction catheter through it.No harm to patient.

• Brand Name: EDI CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): MAQUET
• MDR Report Key: 3983605
• MDR Text Key: 4749304
• Report Number: MW5037630
• Device Sequence Number: 1
• Product Code: KNT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 92117646
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/31/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 1 MO