MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. PORTEX BLUE LINE ULTRA CUFFED TRACHEOSTOMY TUBE; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	100/815/070
Medical Device Problem Codes	Labelling, Instructions for Use or Training Problem (1318); Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	05/31/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Information was received that a patient's respiratory care team opened a "#7 (outer package)" smiths medical portex blue line ultra cuffed tracheostomy tube and required an emergent placement into the patient.After approximately 5-10 minutes in use, it was noticed that the tracheostomy (trach) had a "number six imprinted on it, and the inner package of the device said #6".The hospital care team (doctors were reported to the in the room as well) noted that the patient's vital signs appeared normal, but their "sat was 90-94%".Subsequently, the patient decannulated and their trach was replaced.It was stated the patient "tolerated well" and their saturation once the patient was back on a ventilator of an unknown brand was 99-100%.No additional adverse patient effects were reported.

• Brand Name: PORTEX BLUE LINE ULTRA CUFFED TRACHEOSTOMY TUBE
• Common Device Name: TUBE TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8741529
• Report Number: 3012307300-2019-02877
• Device Sequence Number: 19426062
• Product Code: JOH
• UDI-Device Identifier: 15019315045349
• UDI-Public: 15019315045349
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K030381
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/27/2019

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: Health Professional
• Device Expiration Date: 12/05/2023
• Device Model Number: 100/815/070
• Device Catalogue Number: 100/815/070
• Device Lot Number: 3735552
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2019
• Initial Report FDA Received Date: 06/27/2019
• 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: Life Threatening; Required Intervention
• Patient Age: 18 YR