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

Model Number 18870

Device Problem Gas/Air Leak (2946)

Patient Problems Stacking Breaths (1593); Low Oxygen Saturation (2477); Unintended Extubation (4564)

Event Date 10/20/2021

Event Type  Injury  

Event Description

According to the reporter, during use, the balloon of the device had a leakage.The patient had a increase heart rate, rapid breathing, sp02 of 90% and the ventilator showed a leak.It was also seen a little liquid when the balloon was withdrawn.The tracheal intubation was replaced urgently.A bedside chest radiograph confirmed the position of the intubation, and the patient¿s breathing and heart rate were better than before.After half an hour, the blood gas was rechecked and the oxygen partial pressure was normal.

Manufacturer Narrative

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

• Brand Name: SHILEY
• 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
• Manufacturer (Section G): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• Manufacturer Contact: avi kluger ; 5920 longbow drive; boulder, CO 80301 ; 3035306582
• MDR Report Key: 12786755
• MDR Text Key: 280579221
• Report Number: 2936999-2021-01092
• Device Sequence Number: 1
• Product Code: BTR
• UDI-Device Identifier: 40884521032522
• UDI-Public: 40884521032522
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K090352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 18870
• Device Catalogue Number: 18870
• Device Lot Number: 20L0289JZX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/26/2021
• Date Device Manufactured: 12/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female