MAUDE Adverse Event Report: PORTEX; TRACHEOSTOMY

Model Number	100/870/085CZ
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Information received a smiths medical tracheostomy|pvc - portex tubes blue line ultra (blu) reported a cuff deflation was noted, test was performed and pressure loss was noticed.No patient adverse events reported.
Event or Problem Description
Sme signed off on report.No product was returned., summary of engineering practice in h 10.
Additional Manufacturer Narrative
Other, other text: the investigation of the complaint was limited because no sample was returned.Customer is claiming cuff leaks which was discovered during pre-use check which is required by instruction for use as10001029-002 rev.100, page 4, instruction for use section, point 1: "the integrity of the cuff and inflation system should be checked prior to insertion".During manufacturing process the devices are 100% 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.History of internal ncrs showed that recently there was raised internal nonconformity report ncr1826 due to cuff tear which was found after inflation test.Corrective actions have been taken including initiation of quality alert, training of whole production during production town hall meeting, replacement of gauges and equipment with sharp edges by blunt versions, warning in manufacturing procedure and establishing better organization on affected workplace.No trend of confirmed complaints in relation with this issue was identified.Unfortunately without the sample we are unable to determine true root cause of this issue.

• Brand Name: PORTEX
• Common Device Name: TRACHEOSTOMY
• MDR Report Key: 11616441
• Report Number: 3012307300-2021-02854
• Device Sequence Number: 14215463
• Product Code: BTO
• UDI-Device Identifier: 15019315104879
• UDI-Public: 15019315104879
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K030570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2021

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: Health Professional
• Device Model Number: 100/870/085CZ
• Device Catalogue Number: 100/870/085CZ
• Device Lot Number: 3980193
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/08/2021
• Supplement Date Received by Manufacturer: 04/30/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 05/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1