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

Model Number	86452
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	07/14/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received a report that the dimensions of the product were blurred.Medtronic received additional information, stating the ink of the product was adhered to the packaging, however, the doctor observed the defect when it was being placed in the patient inside trachea.There was no patient harm, however, recannulation of a replacement tube was required.

• Brand Name: MALLINCKRODT, INTERMEDIATE HI-LO TRACHEAL TUBE
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez,mex 32590 ; MX 32590
• MDR Report Key: 6819120
• Report Number: 2936999-2017-05422
• Device Sequence Number: 16177667
• Product Code: BTR
• UDI-Device Identifier: 60884522000487
• UDI-Public: 60884522000487
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K965132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/02/2017

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: 06/12/2021
• Device Model Number: 86452
• Device Catalogue Number: 86452
• Device Lot Number: 16F0415JZX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2017
• Initial Report FDA Received Date: 08/24/2017
• 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