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

Model Number	6DCFS
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Codes	Discomfort (2330); Extubate (2402); Blood Loss (2597)
Date of Event	07/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, post-operatively, the devices' inner cannulas extend too far past the end of the tracheostomy tube which induced discomfort (caused painful and scratchy feeling) as well as increased bleeding (did not exceed 500cc) and drainage.It was indicated that recannulation/decannulation was necessary.
Additional Manufacturer Narrative
Evaluation summary: a second sample of cuffless tracheostomy tube was received for evaluation.The received components are one outer cannula, one dispos able inner cannula size 6 and one obturator.A dimensional test was performed, the inner cannula was inserted inside the outer cannula, it was observed the distal end of the inner cannula protruded 0.071 inches out of the outer cannula, this protrusion is within specification (+/-0.125 inches) according to process instruction hhp-71078 rev g, this dimension was taken using caliper calibration number 9790, the inner cannula was inserted in the fixture with calibration number 13642 and its dimension is within specification.No failure mode was observed in the received sample since met with the product specifications and no corrective actions are required.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: 8131639
• Report Number: 2936999-2018-00751
• Device Sequence Number: 16206188
• Product Code: JOH
• UDI-Device Identifier: 10884522006620
• UDI-Public: 10884522006620
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K962173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2019

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: 05/24/2022
• Device Model Number: 6DCFS
• Device Catalogue Number: 6DCFS
• Device Lot Number: 17E0892JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 03/01/2019
• 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: Other
• Patient Age: 66 YR