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

Catalog Number 100/890/090CZ

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that fissures were observed on the inner cannula of a tracheostomy tube at the moment of cleaning.The inner cannula had been split along the entire outer curve.Customer had to change the inner cannula.No patient details were provided.

• Brand Name: PORTEX® UNIPERC® TRACHEOSTOMY TUBE INNER CANNULAE
• 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 CZECH REPUBLIC A. S.; olomoucka 306; hranice 1 - mesto; hranice, 75301 ; EZ 75301
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7558058
• MDR Text Key: 109752754
• Report Number: 3012307300-2018-02038
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019315107184
• UDI-Public: 15019315107184
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K083031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 100/890/090CZ
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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