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

Model Number	6LPC-S
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/13/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a communication that while in use on a patient, after a few days of use, it was confirmed that the pilot balloon did not work (could not deflate) while checking the cuff.According to the reporter, several attempts were made and the balloon started working normally, but it was replaced as a precaution.The customer indicated that there was no patient harm.
Additional Manufacturer Narrative
Evaluation summary: the sample was received for evaluation and the reported event of cuff breakage was confirmed.Inflation/deflation testing performed found the cuff deflated immediately.Visual inspection performed confirmed a cut in the cuff.Manufacturing controls are in place to detect damage and to reduce the potential for occurrence during the manufacturing process.The damage observed in the sample would have been detected during the manufacturing process.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: 6999931
• Report Number: 2936999-2017-05589
• Device Sequence Number: 16466856
• Product Code: JOH
• UDI-Device Identifier: 20884522031971
• UDI-Public: 20884522031971
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K962173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2018

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: 10/24/2021
• Device Model Number: 6LPC-S
• Device Catalogue Number: 6LPC-S
• Device Lot Number: 16J0566JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Initial Date Received by Manufacturer: 10/16/2017
• Supplement Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 11/03/2017
• Supplement Report FDA Received Date: 02/05/2018
• 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