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

Model Number	8PERC
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	12/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
One sample of device was received for evaluation.The reported condition was confirmed.A visual inspection was performed and it was observed the tube presents signs of being used.The severity was assessed as 8 (loss of primary function).Device or item inoperable.Replacement or repair is required to obtain desired performance.No corrective actions required since the returned sample comply with the current product specifications and process controls established at the manufacturing site.Replacement or repair is required to obtain desired performance.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.
Event or Problem Description
According to the reporter, the device had broken white piece on top of the flange.It was stated that the separation of white piece noticed during changing of inner cannula.The patient had a replacement of the tube.

• Brand Name: SHILEY
• Common Device Name: 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: 9708985
• Report Number: 2936999-2020-00118
• Device Sequence Number: 3474515
• Product Code: BTO
• UDI-Device Identifier: 30884522006709
• UDI-Public: 30884522006709
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K884730
• 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
• Report Date (Section B): 02/13/2020

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: 10/23/2023
• Device Model Number: 8PERC
• Device Catalogue Number: 8PERC
• Device Lot Number: 18J0641JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 02/13/2020
• 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: 57 YR
• Patient Weight: 86