MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX® SUCTIONAID® TRACHEOSTOMY TUBE; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/515/075

Device Problem Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).This device is same and/or similar to a device approved for distribution in the us.

Event Description

It was reported that the cuff of a portex® suctionaid® tracheostomy tube inflated normally during pre-use check, but not after it was intubated in the patient.No injury was reported.

Manufacturer Narrative

Two used samples were received for investigation.A visual inspection could not find any holes.Use testing was able to confirm to the reported problem as leakage was detected in the cuffs of both samples.A manufacturing review of a similar device was conducted and no discrepancies were found.A root cause for the defect could not be determined.

• Brand Name: PORTEX® SUCTIONAID® TRACHEOSTOMY TUBE
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7332051
• MDR Text Key: 102205688
• Report Number: 3012307300-2018-00397
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/06/2020
• Device Catalogue Number: 100/515/075
• Device Lot Number: 3521444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/21/2018
• Initial Date FDA Received: 03/12/2018
• Supplement Dates Manufacturer Received: 05/04/2018
• Supplement Dates FDA Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1