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

Model Number	3.5PED
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/22/2018
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, post-operatively, the device¿s flange was broken.The customer indicated that there were no patient symptoms or complications associated with this event.
Additional Manufacturer Narrative
Evaluation summary: the 3.5ped tracheostomy tube with lot 16g0652jzx was received for evaluation.A visual inspection was performed, confirming one of the flange eyelets is broken.The damage observed is not related to the manufacturing process.We are unable to identify a root cause or speculate on a probable root cause.The device history record for lot 16g0652jzx was reviewed confirming it was manufactured and released accomplishing all quality specifications and requirements.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); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• MDR Report Key: 7397818
• Report Number: 2936999-2018-00228
• Device Sequence Number: 19010042
• Product Code: JOH
• UDI-Device Identifier: 30884522026707
• UDI-Public: 30884522026707
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K945513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2020

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: 07/27/2021
• Device Model Number: 3.5PED
• Device Catalogue Number: 3.5PED
• Device Lot Number: 16G0652JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Initial Date Received by Manufacturer: 03/28/2018
• Supplement Date Received by Manufacturer: 01/31/2020
• Initial Report FDA Received Date: 04/04/2018
• Supplement Report FDA Received Date: 02/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1