MAUDE Adverse Event Report: MMJ SA DE CV (USD) MALLINCKRODT; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number 18880

Device Problem Contamination of Device Ingredient or Reagent (2901)

Patient Problem No Information (3190)

Event Date 05/01/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, three days after switching from mask ventilation to tracheal tube, the hospitalized patient's condition suddenly changed.An x-ray was taken and cylindrical foreign material was found.They guessed the foreign material was found in the patient's airway.There were 4 slits of 1 cm in length and 5 mm in diameter.

Manufacturer Narrative

Evaluation summary: the sample was not received for evaluation and the reported issue was not confirmed; however, photos were provided, and they show a white cylindrical component which does not belong to device bill of material.Therefore, it can be concluded that the cylindrical part observed in the photos is not a component from the device.Information has been added to the database and trends will continue to be monitored.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MALLINCKRODT
• Type of Device: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• MDR Report Key: 8695875
• MDR Text Key: 147895198
• Report Number: 2936999-2019-00396
• Device Sequence Number: 1
• Product Code: BTR
• UDI-Device Identifier: 30884521032549
• UDI-Public: 30884521032549
• Combination Product (y/n): N
• PMA/PMN Number: K090352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 18880
• Device Catalogue Number: 18880
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention