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

Model Number	18785
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during extubation, they could not deflate the air from the inflation line when they tried it with a syringe.It was reported that they had to cut the inflation line to extubate the patient.There was no patient harm.

• Brand Name: MALLINCKRODT
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): COVIDIEN LP JUAREZ (MMJ); 9560 jose rodriguez dr; el paso 79927 ; TX 79927
• MDR Report Key: 8866609
• Report Number: 2936999-2019-00520
• Device Sequence Number: 14087516
• Product Code: BTR
• UDI-Device Identifier: 50884522007625
• UDI-Public: 50884522007625
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K090352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/06/2019

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: 04/09/2023
• Device Model Number: 18785
• Device Catalogue Number: 18785
• Device Lot Number: 18D0250JZX
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 08/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1