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

Model Number	5.0PED
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	12/16/2019
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, the unit had always been passed to the patient from the hospital, but the patient pointed out that a pinkish stain was found to be attached around the base of the actual product.Recannulation was required.
Additional Manufacturer Narrative
Additional information: d3(street 1, mfr city, country code, postal code), d10, g4, h3, h6 h3 evaluation summary: one sample of device was received for evaluation.A visual inspection was performed and it was observed the area around the tube where is inserted into the flange presents a pink discoloration.The reported failure was confirmed.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 TX 32590 ; MX 32590
• MDR Report Key: 9529988
• Report Number: 2936999-2019-01065
• Device Sequence Number: 2282844
• Product Code: JOH
• UDI-Device Identifier: 30884522026738
• UDI-Public: 30884522026738
• 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: consumer,distributor,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2020

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: 05/12/2020
• Device Model Number: 5.0PED
• Device Catalogue Number: 5.0PED
• Device Lot Number: 15E0314JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2020
• Initial Date Received by Manufacturer: 12/16/2019
• Supplement Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 12/30/2019
• Supplement Report FDA Received Date: 03/11/2020
• 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