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

Catalog Number 100/523/080

Device Problems Break (1069); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/26/2017

Event Type  malfunction  

Manufacturer Narrative

It was reported that the catalog number of the affected device was 100/523/070, however, the reported lot number of 3178621 corresponds with the catalog number of 100/523/080.Customer has not returned the device to the manufacturer for device evaluation.If the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.

Event Description

It was reported that when the product was in use, the "fixing hole" of a portex® adjustable flange tracheostomy tube was broken and "the product could not be fixed".No injury was reported.

• Brand Name: PORTEX® ADJUSTABLE FLANGE 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 HEALTHCARE MFG; s.a. de c.v. ave calidad no. 4; parque industrial internaciona; tijuana, 22425 ; MX 22425
• Manufacturer Contact: jennifer meng ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833078
• MDR Report Key: 6667521
• MDR Text Key: 78408331
• Report Number: 3012307300-2017-01364
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 06/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2021
• Device Catalogue Number: 100/523/080
• Device Lot Number: 3178621
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/08/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2016
• 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