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

Model Number	8CN85H
Medical Device Problem Codes	Use of Device Problem (1670); Component Missing (2306)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	10/22/2019
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, trach cuff balloon will not hold air.Patient required removal of existing tracheostomy and replacement at bedside.They attempted to replace tracheostomy using bedside emergency trach from emergency trach supplies.After removing previous trach and opening new trach from supplies, noted to have wrong trach.Existing trach had cuff, available replacement trach had no cuff.Patient required re-intubation at bedside.Both trachs were correct size and "navy" color, one having a cuff and the none for the other.
Event or Problem Description
According to the reporter, trach cuff balloon will not hold air.Patient required removal of existing tracheostomy and replacement at bedside.They removed attempted to replace tracheostomy using bedside emergency trach from emergency trach supplies.After removing previous trach and opening new trach from supplies, noted to have wrong trach.Existing trach had cuff, available replacement trach had no cuff.Patient required re-intubation at bedside.Both trachs were correct size and "navy" color, one having a cuff and the other none.
Additional Manufacturer Narrative
Additional information: a1, b5, d4(model#, catalog#, expiration date, lot#, udi), d10, g4, h3, h6 h3 evaluation summary: the sample was received for evaluation and no reported event was observed in the received sample since met with the product specific ations.All the components are assembled properly at the tube, printing on the flange and code color is according to the drawing.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: 9502106
• Report Number: 2936999-2019-01047
• Device Sequence Number: 11060184
• Product Code: JOH
• UDI-Device Identifier: 20884521176260
• UDI-Public: 20884521176260
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K142296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2020

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: 09/30/2023
• Device Model Number: 8CN85H
• Device Catalogue Number: 8CN85H
• Device Lot Number: 18J0004JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2020
• Initial Date Received by Manufacturer: 12/06/2019
• Supplement Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 12/20/2019
• Supplement Report FDA Received Date: 03/30/2020
• 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
• Patient Age: 73 YR