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

Model Number	18870
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	04/21/2019
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, cuff leakage was found during intubation management.It was indicated that recannulation of a replacement tube was required.
Additional Manufacturer Narrative
Evaluation summary: one sample was received for evaluation, and evaluation and the reported event was not confirmed as related with the manufacturing process.A visual inspection was performed, and it was observed the cuff presents two small cuts.An inflation/deflation test was performed, air was applied to the cuff using a syringe and it was observed the cuff deflated after few seconds.Instructions for use (ifu) information states that to test the cuff, pilot balloon and valve for integrity by inflation prior to use.Insert a luer tip syringe into the cuff inflation valve housing and inject enough air to fully inflate cuff.After test inflation, completely evacuate the air.Each tube's cuff, pilot balloon and valve should be tested by inflation prior to use.If dysfunction is detected in any part of the inflation system, the tube should not be used and should be returned.Do not overinflate the cuff.Ordinarily, the cuff pressure should not exceed 25 cmh20.Overinflation can result in tracheal damage, rupture of the cuff with subsequent deflation, or in cuff distortion which may lead to airway blockage.Various bony anatomical structures (e.G., teeth, turbinates) within the airway or any intubation tools with sharp surfaces might jeopardize cuff integrity.Damage to the thin-walled cuff during insertion will subject the patient to the risk of extubation and re-intubation.If the cuff is damaged, the tube should not be used.Information has been added to the database and trends will continue to be monitored.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
• MDR Report Key: 8613058
• Report Number: 2936999-2019-00345
• Device Sequence Number: 1756725
• Product Code: BTR
• UDI-Device Identifier: 30884521032525
• UDI-Public: 30884521032525
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K090352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2019

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: 18870
• Device Catalogue Number: 18870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Initial Date Received by Manufacturer: 04/24/2019
• Supplement Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 09/04/2019
• 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: Required Intervention