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

Catalog Number 100/860/070CZ

Device Problem Material Integrity Problem (2978)

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

Event Date 01/08/2019

Event Type  malfunction  

Event Description

Information was received that a smiths medical blue line ultra suctionaid tracheostomy tube kit had a crack on the blue connect tip of the suction port.This was noted while connecting the luer lock 10ml syringe, resulting in excess moisture on the site, causing discomfort to the patient.No patient injury occurred and no medical intervention was required.

Manufacturer Narrative

One tracheostomy was returned for evaluation.Visual inspection of the device found it to be in good condition.No crack on the suction line was visible.Then a syringe was inserted into blue hub and reported split was observed (see photo of defect).Suction connector is clearly broken (across its length) which is resulting to leak between syringe and connector connection.This confirms the reported customer complaint.While no definitive root cause to the reported issue could be determined, this investigation revealed no intrinsic evidence to suggest a root cause related to manufacturing.

• 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: 8318009
• MDR Text Key: 135708485
• Report Number: 3012307300-2019-00637
• 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: 04/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 100/860/070CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2019
• Date Manufacturer Received: 03/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening