MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. 8.0MM BLUE LINE ULTRA® SUCTIONAID® TRACHEOSTOMY TUBE KIT WITH 15MM CONNECTOR, SO; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 100/870/080CZ

Device Problem Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2016

Event Type  malfunction  

Manufacturer Narrative

Customer has not yet returned the device to the manufacturer for device evaluation.When and if the device becomes available and is returned and evaluated the manufacturer will file a follow-up report detailing the results of the evaluation.(b)(4).

Event Description

It was reported that the cuff on a tracheostomy tube kit had a 2.0mm hole and was not able to be "blocked" after being placed.It was reported that the tracheostomy tube was changed on a regular basis.The tracheostomy tube was removed and another new tracheostomy tube was successfully placed.No adverse health outcomes were reported.

• Brand Name: 8.0MM BLUE LINE ULTRA® SUCTIONAID® TRACHEOSTOMY TUBE KIT WITH 15MM CONNECTOR, SO
• 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 NIJMEGEN; bijsterhuizen 22 - 08; wijchen, 6604 LD; NL 6604 LD
• Manufacturer Contact: lisa perz ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833074
• MDR Report Key: 6188821
• MDR Text Key: 62852600
• Report Number: 3012307300-2016-00584
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 100/870/080CZ
• Device Lot Number: 3227020
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2016
• 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
• Patient Age: 82 YR