MAUDE Adverse Event Report: MMJ SA DE CV (USD) SHILEY; TUBE TRACHEOSTOMY AND TUBE CUFF

Model Number	4.0PED
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/13/2019
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, prior to use, there was a strong resistance felt when removing the obturator.There was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary: one sample of device was received for evaluation.The reported event was confirmed.A functional test was performed and no obstruction or difficulties were detected during the test.No failure mode was observed in the received sample.A visual test was performed and it was observed all the components are assembled properly at the tube.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 TRACHEOSTOMY AND TUBE CUFF
• Manufacturer (Section D): MMJ SA DE CV (USD); 9560 jose rodriguez drive; el paso TX 79927
• MDR Report Key: 9161157
• Report Number: 2936999-2019-00825
• Device Sequence Number: 1912688
• Product Code: JOH
• UDI-Device Identifier: 30884522026714
• UDI-Public: 30884522026714
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K945513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2019

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: 12/13/2023
• Device Model Number: 4.0PED
• Device Catalogue Number: 4.0PED
• Device Lot Number: 18L0290JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Initial Date Received by Manufacturer: 09/13/2019
• Supplement Date Received by Manufacturer: 11/28/2019
• Initial Report FDA Received Date: 10/07/2019
• Supplement Report FDA Received Date: 12/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1