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

Model Number	4.0PED
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/21/2018
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, prior to use, tubing was discolored.There was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary: the incident sample was returned for evaluation and a visual inspection revealed there was some discoloration of the tube.A review of manufacturing process revealed that the container used to wash the tubing , using lysol and water, was too small and the liquids were not fully mixed together which probably caused the discoloration.The work instruction for this step of the manufacturing process was updated with pictures and comments to ensure the proper size of container will be used for this step of the process.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
This event has been reassessed and found to be a non-mdr reportable complaint.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,ci 32590 ; MX 32590
• MDR Report Key: 7666733
• Report Number: 2936999-2018-00432
• Device Sequence Number: 11420453
• 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,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/19/2018

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: 05/09/2022
• Device Model Number: 4.0PED
• Device Catalogue Number: 4.0PED
• Device Lot Number: 17E0250JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Initial Date Received by Manufacturer: 06/21/2018
• Supplement Date Received by Manufacturer: 09/05/2018; 09/05/2018
• Initial Report FDA Received Date: 07/06/2018
• Supplement Report FDA Received Date: 10/04/2018; 10/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1