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

Model Number	86111-
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	04/10/2019
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 a surgery, the anesthesiologist was having more and more trouble ventilating the patient and decided to re-intubate the patient.After removing the original tube and checking the balloon on it, it was found to have a large bulge out the side, causing compression on other parts of the airway.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: one sample was received for evaluation.The failure cuff distortion was confirmed in the received sample.Manufacturing process was reviewed and currently, there is no potential risk and the below conditions were found.An inflation test is performed for all products.The operator inspects all products for leaks and hernias and segregates the defective parts.All manufacturing controls were found acceptable and effective to detect the reported failure mode.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 desarrol; ciudad juarez,mx 32590 ; MX 32590
• MDR Report Key: 8618477
• Report Number: 2936999-2019-00355
• Device Sequence Number: 10824297
• Product Code: BTR
• UDI-Device Identifier: 40884522000117
• UDI-Public: 40884522000117
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K871204
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/09/2019

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 Expiration Date: 01/07/2024
• Device Model Number: 86111-
• Device Catalogue Number: 86111-
• Device Lot Number: 19A0092JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Initial Date Received by Manufacturer: 04/22/2019
• Supplement Date Received by Manufacturer: 04/23/2019; 09/19/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 05/28/2019; 10/09/2019
• 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
• Patient Age: 48 YR
• Patient Weight: 149