MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. PORTEX ENDOTRACHEAL TUBES SACETT; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	100/189/080
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient had been intubated for 48 hours with stable respiratory.A bronchoscopy was done to check for possible aspergillosis and it was seen that the tube seemed to be disintegrating from the inner layer.The middle lower part of the tube seemed to be shedding.No medical or surgical intervention was reported.
Additional Manufacturer Narrative
This mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A product sample and a photo were received for evaluation.Per photo received, its not possible to confirm the reported failure mode.Per visual inspections, no defects could be observed in sample received.No other analysis was performed.Root cause cannot be determined since no defects were detected in the sample returned for evaluation.No action was taken since the reported failure mode was not confirmed.No problems or issues were identified during this device history record review.Operator of device is unknown.

• Brand Name: PORTEX ENDOTRACHEAL TUBES SACETT
• Common Device Name: TUBE, TRACHEAL (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: jim vegel
• MDR Report Key: 16727468
• Report Number: 3012307300-2023-04037
• Device Sequence Number: 8116566
• Product Code: BTR
• UDI-Device Identifier: 15019315059544
• UDI-Public: 15019315059544
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K081086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 10/13/2025
• Device Model Number: 100/189/080
• Device Catalogue Number: 100/189/080
• Device Lot Number: 4020936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown