MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	100/870/060CZ
Medical Device Problem Code	Pressure Problem (3012)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/12/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received indicating that a smiths medical tracheotomy cuff wasn't keeping air pressure after using the cuff pressure gauge.There were no adverse events reported.
Additional Manufacturer Narrative
Corrected data: changed from malfunction to a serious injury.
Additional Manufacturer Narrative
Under visual inspection the sample appeared to be in good condition.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.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.No trend of similar customer complaints was identified.
Event or Problem Description
Investigation completed and summarized in h 10.
Additional Manufacturer Narrative
Under visual inspection the sample appeared to be in good condition.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.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.No trend of similar customer complaints was identified.

• Brand Name: PORTEX
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• MDR Report Key: 10541433
• Report Number: 3012307300-2020-09390
• Device Sequence Number: 2803311
• Product Code: BTO
• UDI-Device Identifier: 15019315104831
• UDI-Public: 15019315104831
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K030570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: No Information
• Device Model Number: 100/870/060CZ
• Device Lot Number: 3817662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2020
• Supplement Date Received by Manufacturer: 09/16/2020; 12/08/2020; 12/08/2020
• Initial Report FDA Received Date: 09/16/2020
• Supplement Report FDA Received Date: 09/16/2020; 01/08/2021; 01/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention