MAUDE Adverse Event Report: COVIDIEN LP MALLINCKRODT; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	86050
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	12/29/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Anesthesia called for difficult intubation.Intubated with 6.5 cuffed ett, upon placing patient on servo, patient quickly desaturated and air noted to be escaping around tube.Anesthesia called back for re-intubation due to defective ett cuff.Defective tube given to charge rn.

• Brand Name: MALLINCKRODT
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): COVIDIEN LP; 710 medtronic parkway; minneapolis MN 55432
• MDR Report Key: 7227327
• Report Number: 7227327
• Device Sequence Number: 1022371
• Product Code: BTR
• UDI-Device Identifier: 50884522005676
• UDI-Public: (01)50884522005676
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/08/2018
• Report Date (Section F): 01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Model Number: 86050
• Device Catalogue Number: 86050
• Device Lot Number: 16L0335JZX
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/08/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/08/2018