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

Model Number 86398

Device Problem Human-Device Interface Problem (2949)

Patient Problems Injury (2348); Extubate (2402)

Event Date 02/18/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, during use, the tip of the tube was not correctly identified due to its image on x-ray and the way it was projected on the x-ray gave a false impression of the tip.It was stated that it resulted in right mainstream intubation, left lung collapse, hypoxia, arterial fibrillation with rapid ventricular response and kidney failure.The patient remains intubated with the device.

Manufacturer Narrative

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

Event Description

According to the reporter, during use, the tip of the tube was not correctly identified due to its image on x-ray and the way it was projected on the x-ray gave a false impression of the tip.It was stated that it resulted in right mainstream intubation, left lung collapse, hypoxia, arterial fibrillation with rapid ventricular response and kidney failure.The device was removed and the patient underwent tracheostomy.

• 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: 8422646
• MDR Text Key: 138851973
• Report Number: 2936999-2019-00188
• Device Sequence Number: 1
• Product Code: BTR
• UDI-Device Identifier: 10884522002066
• UDI-Public: 10884522002066
• Combination Product (y/n): N
• PMA/PMN Number: K873461
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 04/02/2019

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
• Device Operator: Health Professional
• Device Model Number: 86398
• Device Catalogue Number: 86398
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2019
• Initial Date FDA Received: 03/14/2019
• Supplement Dates Manufacturer Received: 03/12/2019
• Supplement Dates FDA Received: 04/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention