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

Catalog Number 100/515/080

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This device is same and/or similar to a device approved for distribution in the us.

Event Description

It was reported that during use of a portex® suctionaid® tracheostomy tube, the "red component", which was supposed to be located in the pilot balloon, was found to be missing, no injury was reported.

Manufacturer Narrative

One portex® suctionaid tracheostomy tube was received for analysis in used condition.The sample was visually inspected at a distance of 12" to 16" under normal conditions of illumination.It was observed that the red adaptor of the inflation line was missing.The manufacturing and quality inspection processes were reviewed and considered adequate and correct.The most probable root cause was determined to be the red check valve with female luer slip taper was received loose from the supplier.

• 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: 7332096
• MDR Text Key: 102204253
• Report Number: 3012307300-2018-00396
• 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: 06/06/2018

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 Catalogue Number: 100/515/080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2018
• 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: 05/09/2018
• Supplement Dates FDA Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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