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

Model Number	100/870/080CZ
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	10/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A product sample was received and is awaiting evaluation and investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that a patient's tracheostomy cuff was deflating within 15mins.Re-inflation of the cuff was not effective for the post decuffing regime.Early intervention was required.The patient was fasted for an urgent tracheostomy change.
Additional Manufacturer Narrative
H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.One used decontaminated sample was returned for investigation.The inflation test was repeated on the received sample.It was found that it is not possible to inflate sample because it leaks so badly.Under closer visual inspection we noticed tear in cuff which caused reported leakage.Each cuff shall be tested by customer prior use as per instruction for use: "the integrity of the cuff and inflation system should be checked prior to insertion".Due to fact that cuff leak was observed after placement it is the most probable that reported failure occurred during tracheostomy procedure due to contact with sharp edge which is in conflict with instruction for use: "guard against cuff damage by avoiding contact with sharp edges".The cause of the reported problem was traced to the user manipulation of the device.No lot number was provided; therefore, dhr (device history review) could not be performed.

• Brand Name: PORTEX BLUE LINE ULTRA SUCTIONAID TRACHEOSTOMY TUB
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer (Section G): NULL; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15737851
• Report Number: 3012307300-2022-26793
• Device Sequence Number: 2959085
• Product Code: BTO
• UDI-Device Identifier: 15019315104862
• UDI-Public: 15019315104862
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 100/870/080CZ
• Device Catalogue Number: 100/870/080CZ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2022
• Supplement Date Received by Manufacturer: 11/15/2022
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 11/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown