MAUDE Adverse Event Report: PORTEX; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	513080
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/23/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Other, other text: one smiths medical tracheostomy|pvc - portex tubes dic was returned for analysis.An attempt was made to inflate cuff of trach by using air filled syringe and holding under water to check for leaks.Cuff would not stay inflated, thus confirming the complaint.Trach was visually examined under 25x magnification which shows cuff has a small hole.Although the damage to the cuff was observed, however it cannot be determined with certainty when and how exactly the cuff was compromised.Based on the available evidence and investigation results the reported by the customer problem was confirmed but the source of the problem could not be identified.
Event or Problem Description
Information was received indicating that the balloon of a smiths medical tracheostomy|pvc - portex tubes dic could not inflate.No adverse effects were reported.

• Brand Name: PORTEX
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• MDR Report Key: 12507187
• Report Number: 3012307300-2021-09497
• Device Sequence Number: 5338287
• Product Code: BTR
• UDI-Device Identifier: 10351688036933
• UDI-Public: 10351688036933
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K934465
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/21/2021

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
• Operator of Device: No Information
• Device Expiration Date: 05/31/2022
• Device Model Number: 513080
• Device Catalogue Number: 513080
• Device Lot Number: 3511932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2021
• Initial Report FDA Received Date: 09/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1