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.

Manufacturer Narrative

Evaluation results: one portex blue line ultra (blu) tracheostomy tube was returned in used condition.Visual inspection revealed that the inner cannulas had split across its length.To verify that the inner cannula durability, the technician carried out informative testing on randomly selected inner cannula samples of each size (6.0mm - 10.0mm, both fenestrated and non-fenestrated versions) from current batches to measure their performance using established standard test methods.Based on the results of the testing of the current blu thin wall inner cannulas it was determined that they were suitable for their intended function.The investigation results indicated that the event was most likely caused by excessive force used during cleaning or due to an incorrect cleaning technique.

• 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
• MDR Report Key: 8375256
• MDR Text Key: 137301367
• Report Number: 3012307300-2019-01047
• Device Sequence Number: 1
• Product Code: OFR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 07/03/2019

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: 3601242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Date Manufacturer Received: 06/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention