MAUDE Adverse Event Report: NULL; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Catalog Number 32-06-004-1

Device Problem Material Fragmentation (1261)

Patient Problem Swelling/ Edema (4577)

Event Type  malfunction  

Event Description

It was reported that the tube tip was mislodged into the entrance of esophagus or left subcutaneous tissue the of the entrance of trachea.The customer inserted the product again and found ventilation of the product was good.The patient was transported to the hospital.No patient injury was reported.

Manufacturer Narrative

Brand unknown, operator of device is unknown.No information has been provided to date.Udi information is unknown, manufacturing site address is unknown.Premarket (510k) number is unknown manufacturing device history record review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section G): NULL
• MDR Report Key: 15442974
• MDR Text Key: 305722098
• Report Number: 3012307300-2022-19544
• 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: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 32-06-004-1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1