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

Model Number	100/870/075CZ
Medical Device Problem Codes	Crack (1135); Fracture (1260)
Health Effect - Clinical Codes	Airway Obstruction (1699); Decreased Respiratory Rate (2485)
Date of Event	04/19/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the trach tube had a subglottic port split; specifically on the blue end where the syringe attaches.This trach tube was inserted on (b)(6) 2022.The customer was unable to aspirate any subglottic secretions.A premature trach tube change (like for like') was successfully completed.The customer was then able to successfully aspirate 3ml of secretions from the replacement device's port.No other information has been provided at this time.
Additional Manufacturer Narrative
Other, review of the device history records show there were no observations recorded during manufacture to suggest an issue of this nature would occur with this lot of product.A product sample was received for evaluation.Visual and functional testing were performed.Under visual inspection suction connector seemed to be without any defect.Under functional testing a syringe was inserted into the connector and crack in connector split line was observed.The root cause of the issue could not be determined - it could be a moulding defect or excessive force used when connector was connected with syringe.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken accordingly.
Additional Manufacturer Narrative
Corrected data: type of reportable event corrected (updated b1).

• Brand Name: PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE
• 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
• Manufacturer (Section G): SMITHS MEDICAL INTERNATIONAL, LTD.; olomoucka 306; hranice 1, mesto 753 0 1; EZ 753 01
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; guy's hospital; minneapolis, MN 55442
• MDR Report Key: 14465975
• Report Number: 3012307300-2022-09346
• Device Sequence Number: 4699370
• Product Code: BTO
• UDI-Device Identifier: 15019315104855
• UDI-Public: 15019315104855
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K030570
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/21/2022

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 Expiration Date: 06/02/2026
• Device Model Number: 100/870/075CZ
• Device Catalogue Number: 100/870/075CZ
• Device Lot Number: 4156859
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/18/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2022
• Supplement Date Received by Manufacturer: 05/30/2022; 06/24/2022
• Initial Report FDA Received Date: 05/21/2022
• Supplement Report FDA Received Date: 06/29/2022; 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/21/2021
• 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