MAUDE Adverse Event Report: MMJ SA DE CV (USD) MALLINCKRODT, 10FR STYLET/TRACHEAL TUBING; STYLET, TRACHEAL TUBE

Model Number	85864
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device in this report is product code: bsr, device class: 1, regulation number: 868.5790 (510k exempt).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report that the unit was having a labeling issue.It was incorrect.The issue was detected in the distribution center, therefore, there was no patient involved in this event.The customer discarded the product.

• Brand Name: MALLINCKRODT, 10FR STYLET/TRACHEAL TUBING
• Common Device Name: STYLET, TRACHEAL TUBE
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez,mex 32590 ; MX 32590
• MDR Report Key: 6774831
• Report Number: 2936999-2017-05394
• Device Sequence Number: 121011
• Product Code: BSR
• UDI-Device Identifier: 60884522004089
• UDI-Public: 60884522004089
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/18/2017

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: 11/01/2021
• Device Model Number: 85864
• Device Catalogue Number: 85864
• Device Lot Number: 16K0104JZX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2017
• Initial Report FDA Received Date: 08/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1