MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number 101/870/080CZ

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 10/06/2020

Event Type  malfunction  

Event Description

Information was received indicating that a smiths medical trach was in use and properly placed but then the medical professional found some water in the pilot balloon.There were no reported adverse events.

Manufacturer Narrative

Additional information: d10 one portex tube was returned for analysis.Under visual inspection the sample appeared to be in good condition, no water in inflation system was observed.During the manufacturing process the devices are 100 percent inflation tested, which includes inflating each device cuff and leaving for a 12 hour period.Reductions in pressure over this time are considered a failure and the device would be rejected.The inflation test was repeated on the received samples.It was confirmed that after 12 hours the cuff was still fully inflated.Based on results of testing the reported failure was not observed - inflation system was confirmed to be closed without any leak which might be entrance point for reported water.The most probable cause is that customer put water into pilot balloon during cuff inflating.No trend of similar customer complaints was identified.

• Brand Name: PORTEX
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• MDR Report Key: 11046540
• MDR Text Key: 222678044
• Report Number: 3012307300-2020-12616
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 15019517076226
• UDI-Public: 15019517076226
• Combination Product (y/n): N
• PMA/PMN Number: K173384
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 02/11/2021

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
• Device Operator: No Information
• Device Model Number: 101/870/080CZ
• Device Lot Number: 3887515
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/23/2020
• Initial Date FDA Received: 12/21/2020
• Supplement Dates Manufacturer Received: 01/13/2021
• Supplement Dates FDA Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1