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

Model Number 100/890/080CZ

Device Problems Material Discolored (1170); Material Too Soft/Flexible (4007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2020

Event Type  malfunction  

Event Description

It was reported the device was in use with patient and was found to be discolored and softer in some areas.No adverse effects reported.

• Brand Name: PORTEX INNER CANNULA
• 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 ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: david halverson ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 10804940
• MDR Text Key: 215260270
• Report Number: 3012307300-2020-11151
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019315107177
• UDI-Public: 15019315107177
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K083031
• 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: 11/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/31/2020
• Device Model Number: 100/890/080CZ
• Device Catalogue Number: 100/890/080CZ
• Device Lot Number: 3075641
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1