MAUDE Adverse Event Report: NULL; TRACHEOSTOMY TUBE

Lot Number 3613156

Device Problems Break (1069); Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2021

Event Type  malfunction  

Event Description

It was reported that during the use of the product, leakage of air from the cuff occurred in the two (2) products consecutively.The customer then checked the patient trachea and tracheostomy aperture, but there was no factor that would lead to such an event.No patient injury was reported.

Manufacturer Narrative

Device evaluation: the returned sample was visually inspected under normal conditions of illumination according site visual inspection procedure.A damage was found on the surface of the cuff in both samples, thus the failure mode reported is confirmed.Cuff damage is usually due to the patient's anatomy or contact with a laryngoscope.The cuff damage resulting from patient anatomy will differ based upon the nature of intubation: ? oral intubation may result in the cuff becoming snagged on the patient?s teeth or dentures (if not removed).? nasal intubation may result from the cuff becoming torn on the patient?s turbinate (nasal concha).According to the visual aid.Which is inside other analysis section of this report, the most probably root cause is the cuff got damaged during an insertion of the tracheostomy tube.No corrective action was required as there is no information to suggest that the product become damaged during manufacturing since product is 100% uson leak tested and each cuff shall be also tested by customer prior use.Dhr review was completed.Review of manufacturing records, relevant to the lot reported, found no discrepancies or anomalies.

• Type of Device: TRACHEOSTOMY TUBE
• Manufacturer (Section G): NULL
• MDR Report Key: 13197886
• MDR Text Key: 285681400
• Report Number: 3012307300-2022-00334
• Device Sequence Number: 1
• Product Code: BTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2023
• Device Lot Number: 3613156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1