MAUDE Adverse Event Report: MMJ SA DE CV (USD); TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	5.5PDL
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	11/07/2017
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
Medtronic received a report that the patient's mother had noticed that there was some irritation on the patients skin.She had attempted to place some gauze between the tracheostomy tube and the patients skin, when she felt a sharp edge on the tracheostomy tube with her hand.The patient had received a superficial cut to the neck that already healed with no long term effects.The tube was removed and replaced.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Device evaluation: one sample was received for evaluation, and the reported condition was confirmed.A visual inspection was performed and it was observed that there was a flash in the injection point at the flange/connector.If information is provided in the future, a supplemental report will be issued.

• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• MDR Report Key: 7067649
• Report Number: 2936999-2017-05639
• Device Sequence Number: 10802071
• Product Code: BTR
• UDI-Device Identifier: 10884522030045
• UDI-Public: 10884522030045
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K945513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/02/2018

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: 05/23/2022
• Device Model Number: 5.5PDL
• Device Catalogue Number: 5.5PDL
• Device Lot Number: 17E0848JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Initial Date Received by Manufacturer: 11/27/2017
• Supplement Date Received by Manufacturer: 01/08/2018; 01/08/2018
• Initial Report FDA Received Date: 11/29/2017
• Supplement Report FDA Received Date: 02/06/2018; 04/02/2018
• 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
• Patient Age: 15 YR
• Patient Weight: 32