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

Model Number	5.0PDC
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, prior to use, an air leakage was found during cuff check.There was no patient involved.
Additional Manufacturer Narrative
Additional information: e1 (street 1), d10 (concomitant medical products), g4 (pma/510k), h3 (device evaluated by mfr), h6, h3 (device evaluated by mfr): evaluation summary: one device was received for evaluation.The reported event was confirmed.An inflation/deflation test was performed, air was applied to the cuff and it was observed the cuff deflated immediately.The sample was submerged into a container filled with water and air was applied and it revealed the tube leaked air through the lumen.A walking process was conducted through pediatric manufacturing area and was found that there was not clearly identified in the work instruction the proper way to proceed once a piece be rejected due the inflation/deflation test; therefore, as a possible root cause was detected an incorrect product handling, in consequence as a corrective action the work instruction was updated in order to clarify the proper way to proceed once a piece was rejected due the inflation/deflation test.Information has been added to the database and trends will continue to be monitored.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• 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: 8600301
• Report Number: 2936999-2019-00335
• Device Sequence Number: 2293258
• Product Code: JOH
• UDI-Device Identifier: 20884522029121
• UDI-Public: 20884522029121
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955680
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/23/2023
• Device Model Number: 5.0PDC
• Device Catalogue Number: 5.0PDC
• Device Lot Number: 18E0666JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2019
• Initial Date Received by Manufacturer: 04/19/2019
• Supplement Date Received by Manufacturer: 10/17/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 11/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1