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

Model Number	85864
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 380 units of lot 16k0104jzx had a labeling issue.The reporter stated that the validity date is divergent between the packaging.

• Brand Name: MALLINCKRODT
• Common Device Name: STYLET, TRACHEAL TUBE
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• MDR Report Key: 6704837
• Report Number: 2936999-2017-05316
• Device Sequence Number: 10983191
• 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: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/19/2017

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: 06/19/2017
• Initial Report FDA Received Date: 07/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1