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

Model Number 8PERC

Device Problem Break (1069)

Patient Problem Extubate (2402)

Event Date 10/11/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, the hinge between the tube and the external transverse portion was broken and have a risk of extruding the entire tube.The hinge was broken on both sides.The customer reported that they had to replace this on patient.

Manufacturer Narrative

Evaluation summary: one sample was received and a visual inspection was conducted.It was observed that the flange was detached from the cannula and it was noticed the flange and the right and left hole of the cannula present damage, which would have been detected immediately in the manufacturing process since that defect is extremely obvious.The failure mode is not confirmed as related with the manufacturing process.Additionally, a dimensional test was performed to the outer cannula holes and flange lug pin and all the readings are according to specification.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 32590 ; MX 32590
• MDR Report Key: 8195672
• MDR Text Key: 131380486
• Report Number: 2936999-2018-00790
• Device Sequence Number: 1
• Product Code: BTO
• UDI-Device Identifier: 30884522006709
• UDI-Public: 30884522006709
• Combination Product (y/n): N
• PMA/PMN Number: K884730
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 03/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2023
• Device Model Number: 8PERC
• Device Catalogue Number: 8PERC
• Device Lot Number: 18A0558JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Date Manufacturer Received: 02/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention