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

Model Number	6.0PDL
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	10/24/2018
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 a discolored part like a stain on the back of the tube.The customer indicated that the patient was recannulated.
Additional Manufacturer Narrative
Evaluation summary: one sample of long pediatric tracheostomy tube was received for evaluation.A visual inspection was performed, and it was observed that the shaft of the tracheostomy tube presents a yellow discoloration.The failure mode discolored is confirmed.Corrective actions have been implemented to mitigate this issue.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: 8083020
• Report Number: 2936999-2018-00708
• Device Sequence Number: 14034841
• Product Code: JOH
• UDI-Device Identifier: 10884522030083
• UDI-Public: 10884522030083
• 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: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2019

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: 11/21/2022
• Device Model Number: 6.0PDL
• Device Catalogue Number: 6.0PDL
• Device Lot Number: 17K0621JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2019
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 11/18/2018
• Supplement Report FDA Received Date: 03/12/2019
• 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: Other