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

Model Number	100/870/075CZ
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2022
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 on routine rounding, tracheostomy physiotherapy team reported that the suction aid port was not working.It was noted that there was a crack in the suction port.Tracheostomy tube had been inserted approximately 14 days prior.Duty intensivist notified and patient was fasted for an urgent tracheostomy tube change and trach tube was changed out.
Additional Manufacturer Narrative
Other, other text: additional information: h6 - health impact codes.H3, h6 - evaluation codes: updated.Device evaluation: one device was returned for investigation.Visual inspection found the suction connector seems to be without any defect.Then a luer slip syringe was inserted into the connector and a crack in the connector split line was observed.The complaint was confirmed.Root cause of this defect is currently unknown.It could be a molding defect or excessive force used when the connector was connected with a syringe during use.A review of the device history record (dhr) shows there were no observations or nonconformities recorded during manufacture to suggest an issue of this nature would occur with this lot of products.No actions taken at this time.This issue will continue to be monitored and further actions taken accordingly.

• Brand Name: PORTEX TUBES BLUE LINE ULTRA (BLU)
• 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: 15625391
• Report Number: 3012307300-2022-24832
• Device Sequence Number: 15008745
• Product Code: BTO
• UDI-Device Identifier: 15019315104855
• UDI-Public: 15019315104855
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/13/2023

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: 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: 10/04/2022
• 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: 09/20/2022
• Supplement Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 10/18/2022
• Supplement Report FDA Received Date: 10/13/2023
• 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