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

Model Number	18880
Medical Device Problem Codes	Air Leak (1008); Inflation Problem (1310)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/31/2018
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, the device cuff started to leak.The product was tested without incident.The patient status was asked but unknown.
Additional Manufacturer Narrative
Evaluation summary: one sample of endotracheal tube was received for evaluation.A visual inspection was performed and it was observed the tube is missing the 15mm connector and the pilot balloon, an inflation/deflation test was performed a syringe needle was connected to the inflation line and 25cc of air was applied to the cuff and it was noticed the cuff held the air, the cuff was left inflated 2 hours according to process instruction, after this time no deflation was observed, additionally the sample was submerged into a container filled with water and no leaks were observed.Information has been added to the database and trends will continue to be monitored.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MALLINCKRODT
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): MMJ SA DE CV(USD); ave henequen no 1181 desarrol; ciudad juarez,mx 32590 ; MX 32590
• MDR Report Key: 7605347
• Report Number: 2936999-2018-00387
• Device Sequence Number: 1242674
• Product Code: BTR
• UDI-Device Identifier: 30884521032549
• UDI-Public: 30884521032549
• 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: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2018

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 Model Number: 18880
• Device Catalogue Number: 18880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Initial Date Received by Manufacturer: 05/31/2018
• Supplement Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 06/15/2018
• Supplement Report FDA Received Date: 10/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1