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

Model Number	100/189/075
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E4 is unknown.No information has been provided to date.H10: device evaluation: one sample was returned for investigation.The sample was received in used condition without the original package.Returned sample was tested to detect any condition that could cause a leak.A leakage was detected in the cuff, which confirmed the complaint.The root cause was that the cuff was damaged during the use of the product since no leaks were reported in the pre-use check and according to the instructions for use the cuff could be damaged due to cuff nicks from teeth or instrumentation during intubation.No corrective action was required as there was no information indicating if the product leaked in the pre-checked that suggest to the instruction for use.A dhr (device history review) was performed subsequent to the manufacturing of the device and prior to its release.No problems or issues were identified during this dhr review.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that a tube was in use on a patient and a leakage of the cuff was found.The tube was changed.No patient injury reported.
Additional Manufacturer Narrative
Serious injury.

• Brand Name: PORTEX
• 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: 16733877
• Report Number: 3012307300-2023-04079
• Device Sequence Number: 6862263
• Product Code: BTR
• UDI-Device Identifier: 15019315059537
• UDI-Public: 15019315059537
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K081086
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/05/2026
• Device Model Number: 100/189/075
• Device Catalogue Number: 100/189/075
• Device Lot Number: 4121719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2022
• Supplement Date Received by Manufacturer: 06/15/2023
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 06/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/31/2021
• 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