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

Model Number	86114
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	08/27/2020
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, patient was intubated with 8.5 ,the tube had 100% leakage.The customer stated they mobilize adequate volumes without desaturations.The balloon was inflated from the pneumotaponator but the balloon was deflated again.The doctor on duty was informed to change the tube, it is changed to a catheter for cold intubation, the tube is changed for 8.5.The patient was mobilizing adequate volumes in the ventilator but it remains de saturated.For what was changed again by means of laryngoscopy, patient was intubated, which is set at 25 cm, is connected again to a mechanical ventilator under the established parameters.Intubation was required.

• 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
• MDR Report Key: 10590697
• Report Number: 2936999-2020-00696
• Device Sequence Number: 13763218
• Product Code: BTR
• UDI-Device Identifier: 10884522000147
• UDI-Public: 10884522000147
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K871204
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2020

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: 86114
• Device Catalogue Number: 86114
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 09/25/2020
• 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: Required Intervention
• Patient Age: 53 YR