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

Catalog Number 100/515/070

Device Problems Deflation Problem (1149); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/16/2016

Event Type  malfunction  

Manufacturer Narrative

Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.Smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.(b)(4).

Event Description

It was reported that there was an issue with the pilot balloon on a tracheostomy tube.After an unknown period of use, the red adaptor on the pilot balloon disconnected, causing a failure of the cuff to deflate.No adverse health outcomes occurred.

Manufacturer Narrative

Two portex® 7.0mm suction aid soft seal cuff tracheostomy tubes were returned for investigation.The devices were received in used condition and without their original packaging.Visual inspection of the returned devices was conducted at a distance of 12" to 24" and under normal conditions of illumination.During examination, one of the devices showed no discrepancies; however, the second device showed that the red check valve with female luer slip taper was missing from the inflation line.Investigation was unable to determine the root cause of the missing red check valve.(b)(4).

• Brand Name: PORTEX® CUFFED BLUE LINE ULTRA® SUCTIONAID
• 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 HEALTHCARE MFG; s.a. de c.v. ave, calidad no.; parque industrial internaciona; tijuana, b.c. 22425 ; MX 22425
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6024465
• MDR Text Key: 57259817
• Report Number: 3012307300-2016-00086
• 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: consumer,foreign,user facilit
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/16/2016

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: Health Professional
• Device Catalogue Number: 100/515/070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/16/2016
• Initial Date FDA Received: 10/12/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/24/2017
• 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: Unknown
• Patient Sequence Number: 1