MAUDE Adverse Event Report: SUNMED HEALTHCARE - AZIMUTH CORPS INTRODUCER, ENDOTRACHEAL TUBE

Catalog Number 9-0212-70

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

Patient Problem No Code Available (3191)

Event Date 05/30/2014

Event Type  Injury  

Event Description

Item failed and broke off in patient's airway.The introducer (bougie) manufactured by sun med, lot number prn05-3446, did not have an expiration date.Equipment with stock numbers have been pulled.Pictures have been included in e-mail.

• Brand Name: INTRODUCER, ENDOTRACHEAL TUBE
• Type of Device: INTRODUCER
• Manufacturer (Section D): SUNMED HEALTHCARE - AZIMUTH CORPS; largo 33773
• MDR Report Key: 3906232
• MDR Text Key: 4674274
• Report Number: MW5036922
• Device Sequence Number: 1
• Product Code: BSR
• 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: 06/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-0212-70
• Device Lot Number: P RN05-3446
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention