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

Model Number	86454
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Information (3190)
Date of Event	10/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the device had a secondary leaking cuff/pilot balloon.
Additional Manufacturer Narrative
Evaluation summary: two photos were provided.One photo presents a pouch and the second photo shows three bags containing the pilot balloon.The device failed to meet specification as it was received or made available for evaluation.An inflation/deflation test is performed for all products.The operator inspects all products for no leaks and segregates the defective parts.All manufacturing controls were found acceptable and effective to detect the reported failure mode.The dhr review shows the product was released to specification.For this complaint the samples were not received for evaluation, only some pictures were received but the failure mode could not be confirmed in those pictures, and without a sample is unable to perform a thorough follow up investigation to include functional and visual evaluation to determine the root cause of the reported condition or implement any corrective action.If the sample is returned at a later date, this complaint will be reopened and the investigation updated to reflect the findings.No new formal investigation is required, the event will be included in trending and monitoring.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the device had a secondary leaking cuff/pilot balloon.There was no reported patient involvement and outcome.

• Brand Name: SHILEY
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): MMJ SA DE CV (USD); 9560 jose rodriguez drive; el paso TX 79927
• MDR Report Key: 9307031
• Report Number: 2936999-2019-00931
• Device Sequence Number: 13919301
• Product Code: BTR
• UDI-Device Identifier: 10884522000505
• UDI-Public: 10884522000505
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K965132
• 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
• Report Date (Section B): 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/06/2023
• Device Model Number: 86454
• Device Catalogue Number: 86454
• Device Lot Number: 18H0141JZX
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/25/2019
• Supplement Date Received by Manufacturer: 01/30/2020
• Initial Report FDA Received Date: 11/11/2019
• Supplement Report FDA Received Date: 02/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1