MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE KIT; TRACHEOBRONCHIAL SUCTION CATHETER KIT

Catalog Number 100/811/080CZ

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2019

Event Type  Injury  

Event Description

Information was received that a smiths medical tracheostomy had a cannula crack, requiring replacement.The incident was reported as being resolved.

• Brand Name: BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUBE KIT
• Type of Device: TRACHEOBRONCHIAL SUCTION CATHETER KIT
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL CZECH REPUBLIC A.S.; olomouck? 306; hranice, mesto 753 0 1; EZ 753 01
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 8375252
• MDR Text Key: 137301326
• Report Number: 3012307300-2019-01048
• Device Sequence Number: 1
• Product Code: OFR
• Combination Product (y/n): N
• Reporter Country Code: RS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 04/10/2023
• Device Catalogue Number: 100/811/080CZ
• Device Lot Number: 3597096
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/27/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention