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

Model Number	6LPC
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Information (3190)
Date of Event	01/23/2019
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, the device had cuff inflation/deflation issue.There was patient involvement with no reported patient outcome.
Additional Manufacturer Narrative
Evaluation summary: sample analysis: one sample was received for evaluation and , the reported event was not confirmed as related with the manufacturing process.The device failed to meet specification as it was received or made available for evaluation.A visual inspection was performed and it was observed the cuff presents a small cut, the reported event on cut in cuff was confirmed.An inflation/deflation test was performed, using a syringe of air was applied to the cuff and it was observed the cuff deflated after few seconds.The investigation of observed condition isolated the failure to the tear on the cuff.Instructions for use (ifu) states that with the cuff and inflation system should be tested for leakage before inserting the tube.This test can be performed as follows: inflate the cuff with the volume of air indicated.Then either observe for deflation over several minutes or immerse the tube in sterile saline and observe for air leakage.Deflate the cuff prior to insertion.To ease insertion and to guard against cuff perforation from sharp edges of cartilage, the cuff should be tapered back.This can be accomplished by first inflating the cuff.Then gently move the cuffaway from the distal tip of the outer cannula towards the swivel neck plate as the residual air is removed by deflation.Do not use any sharp instruments such as forceps or hemostats that would damage the cuff when tapering it.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: 8384450
• Report Number: 2936999-2019-00156
• Device Sequence Number: 1795519
• Product Code: JOH
• UDI-Device Identifier: 60884522007134
• UDI-Public: 60884522007134
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2019

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: 03/29/2022
• Device Model Number: 6LPC
• Device Catalogue Number: 6LPC
• Device Lot Number: 17C0761JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Initial Date Received by Manufacturer: 02/06/2019
• Supplement Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 03/02/2019
• Supplement Report FDA Received Date: 08/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1