MAUDE Adverse Event Report: GARRET DILATOR 1.0MM 5570-03 LP-030416

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

Pediatric liver transplant utilized a dilator for the first time use and the tip broke off in liver.Instrument info: garret dilator 1.0mm 5570-03 lp-030416, unable to retrieve tip and pt monitored.

• Brand Name: GARRET DILATOR 1.0MM 5570-03 LP-030416
• Type of Device: GARRET DILATOR 1.0MM 5570-03 LP-030416
• MDR Report Key: 7681313
• MDR Text Key: 113930818
• Report Number: MW5078347
• Device Sequence Number: 1
• Product Code: FFP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization