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

Model Number	18760
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/30/2018
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, prior to use, there was an air leaking when inflating the device¿s cuff.It was reported that the tip part of the cuff seemed to be distorted when inflated.The customer reported that there was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary: one sample of device was received for evaluation.It was observed the cuff deflated immediately.A visual inspection was conducted and it was observed the cuff presents a cut.The reported event was confirmed.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: 7903100
• Report Number: 2936999-2018-00607
• Device Sequence Number: 1394985
• Product Code: BTR
• UDI-Device Identifier: 80884522007572
• UDI-Public: 80884522007572
• 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: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2018

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 Expiration Date: 01/21/2023
• Device Model Number: 18760
• Device Catalogue Number: 18760
• Device Lot Number: 18A0449JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Initial Date Received by Manufacturer: 09/03/2018
• Supplement Date Received by Manufacturer: 10/26/2018
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 11/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1