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

Model Number	18890S
Medical Device Problem Code	Installation-Related Problem (2965)
Health Effect - Clinical Codes	Low Oxygen Saturation (2477); Unintended Extubation (4564)
Date of Event	09/30/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the reporter, during use, the cuff of the device had a leakage. the respiratory therapist (rt) attempted to put air in the cuff several times but the leakage was still present.Reintubation was required with larger one.The patient was preoxygenated with 100%.Ventilator was disconnected and a bougie was placed into the existing tube and removed.The 9.0 ett was inserted over the bougie.As the tube advanced into the airway, a resistance was felt.The patient saturation began to drop into the mid 80s.The bougie and tube were removed from the airway and patient was bagged.The patient was reintubated with a 7.5 ett which was secured at 24 at the lip.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: SHILEY
• 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
• Manufacturer (Section G): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• Manufacturer Contact: clay chandler ; 5920 longbow drive; boulder, CO 80301 ; 3035306409
• MDR Report Key: 13633654
• Report Number: 2936999-2022-00162
• Device Sequence Number: 14752747
• Product Code: BTR
• UDI-Device Identifier: 10884521726734
• UDI-Public: 10884521726734
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K090352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/01/2022

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: 18890S
• Device Catalogue Number: 18890S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 03/01/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown