MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. ENDOTRACHEAL TUBE STYLET, 6FR

Catalog Number DYND43506

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/16/2014

Event Type  Injury  

Event Description

A piece of the stylet apparently broke off inside a pt.

Manufacturer Narrative

It was reported that a piece of the plastic covering on the endotracheal stylet broke off inside the lung of a young pt.We have attempted to gather details from the facility regarding the incident but have not received any further info.It is not know if any injury resulted and what, if any, medical intervention was required.We have no sample or photos to evaluate.The incident has not been confirmed and a root cause has not been determined.We have not had any other similar complaints reported to us for this device.

• Brand Name: ENDOTRACHEAL TUBE STYLET, 6FR
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; mundelein IL 60060
• Manufacturer Contact: julie finley ; one medline place; mundelein, IL 60060 ; 8476434709
• MDR Report Key: 3836238
• MDR Text Key: 4450923
• Report Number: 1417592-2014-00051
• Device Sequence Number: 1
• Product Code: BSR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/16/2014

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?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DYND43506
• Device Lot Number: 1211021792
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other