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

Model Number	86398
Medical Device Problem Code	Human-Device Interface Problem (2949)
Health Effect - Clinical Codes	Injury (2348); Extubate (2402)
Date of Event	02/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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
• Common Device Name: 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
• Report Number: 2936999-2019-00188
• Device Sequence Number: 2051124
• Product Code: BTR
• UDI-Device Identifier: 10884522002066
• UDI-Public: 10884522002066
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K873461
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 86398
• Device Catalogue Number: 86398
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/19/2019
• Supplement Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 04/02/2019
• 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: Life Threatening; Required Intervention