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

Model Number	4CN65A
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2020
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 sub cannula was not locked, did not click when the patient coughs and it was expelled.It was indicated that there were bleeding and difficulty in cleaning of tracheostomized patient.
Additional Manufacturer Narrative
Additional information: b1, b2(removed other), d3(street 1, mfr city, country code, postal code), e3, g4, h1.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 TX 32590 ; MX 32590
• MDR Report Key: 9641899
• Report Number: 2936999-2020-00064
• Device Sequence Number: 19343074
• Product Code: JOH
• UDI-Device Identifier: 10884521172456
• UDI-Public: 10884521172456
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K142296
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2020

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: 08/13/2022
• Device Model Number: 4CN65A
• Device Catalogue Number: 4CN65A
• Device Lot Number: 17H0379JZX
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 02/17/2020
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 02/19/2020
• 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: Other
• Patient Age: 8 YR
• Patient Weight: 26