MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX TUBES PDT UNIPERC; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number	100/897/070
Medical Device Problem Codes	Disconnection (1171); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2023, a tracheostomy tube was placed in the patient during an or procedure.On (b)(6) 2023, the bedside rrt noticed that the white adapter of the trach tube was loose and detaching from the trach tube (clear plastic trach tube slid off of trach adaptor).Multiple attempts were made to reattach the adapter but it would not stay in place.Because the patient required mechanical ventilation, the rrt had to stay at the bedside to hold the trach and adapter together until help arrived to change out the tube.The intensivist was promptly notified of the situation and arrangement were made to exchange the tube under visualization with a fiberoptic bronchoscope.The defective trach was removed over the bronch to ensure airway patency and integrity.Once this was established, a new tracheostomy tube from a different manufacturer was inserted without incident and placement was assessed and verified with bronchoscope."no serious harm" reported.
Additional Manufacturer Narrative
Lot number, expiration date and device manufacture date is unknown, no information has been provided to date.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.
Additional Manufacturer Narrative
Email is: regulatory.Responses@icumed.Com.One used decontaminated device sample was received in a plastic bag without its original packaging.Under visual inspection it was noticed the white connector was detached from the tube.The complaint was confirmed.A root cause of this issue was unable to be identified.A device history record (dhr) review could not be performed as the lot number was unknown.Complaint history was checked, and no trend of confirmed customer complaints was identified.The issue will be monitored for threshold or escalation.
Additional Manufacturer Narrative
Insufficient information was provided to be able to determine the full udi.**udi related data quality updates only** .

• Brand Name: PORTEX TUBES PDT UNIPERC
• Common Device Name: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• Manufacturer (Section G): NULL
• Manufacturer Contact: reed covert ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 17966132
• Report Number: 3012307300-2023-09756
• Device Sequence Number: 6800187
• Product Code: BTO
• UDI-Device Identifier: 15019315060434
• UDI-Public: 15019315060434
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K083031
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/01/2024

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 Catalogue Number: 100/897/070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 09/22/2023
• Supplement Date Received by Manufacturer: 01/22/2024; Not provided
• Initial Report FDA Received Date: 10/19/2023
• Supplement Report FDA Received Date: 01/24/2024; 08/08/2024
• 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