MAUDE Adverse Event Report: MMJ SA DE CV (USD) SHILEY; TUBE, TRACHEOSTOMY (W/WO CONNECTOR)

Model Number 6DIC

Device Problem Contamination of Device Ingredient or Reagent (2901)

Patient Problem No Patient Involvement (2645)

Event Date 04/01/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during routine inner cannula change, an extra plastic was noted beneath the wing on one side of the cannula.The customer reported that there was no patient involvement.

Manufacturer Narrative

Evaluation summary: one sample of disposable inner cannula was received for evaluation.A visual inspection was performed and it was observed the cannula present a piece of plastic attached under the connector snap, the failure mode flash is confirmed.The investigation could not determine a cause of the event.The product relates to the reported complaint event.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
• Type of Device: TUBE, TRACHEOSTOMY (W/WO CONNECTOR)
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez,ci 32590 ; MX 32590
• MDR Report Key: 7458655
• MDR Text Key: 106618012
• Report Number: 2936999-2018-00299
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 50884522005287
• UDI-Public: 50884522005287
• Combination Product (y/n): N
• PMA/PMN Number: K811447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/17/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 01/25/2023
• Device Model Number: 6DIC
• Device Catalogue Number: 6DIC
• Device Lot Number: 18A0746JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2018
• Initial Date Manufacturer Received: 04/12/2018
• Initial Date FDA Received: 04/25/2018
• Supplement Dates Manufacturer Received: 12/19/2018
• Supplement Dates FDA Received: 01/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1