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

Model Number	86265
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
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 unit tube was kinked.There was no patient involvement.
Event or Problem Description
According to the reporter, the unit had a package integrity issue which caused the tube to be kinked.There was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary: the reported complaint was verified from the pictures provided.The unit was evaluated.The tube is seemed to be kinked in the packaging which is not yet opened.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 desarroll; ciudad juarez 32590 ; MX 32590
• MDR Report Key: 8131670
• Report Number: 2936999-2018-00755
• Device Sequence Number: 13841152
• Product Code: BTR
• UDI-Device Identifier: 10884522024471
• UDI-Public: 10884522024471
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K871204
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2019

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: 05/24/2022
• Device Model Number: 86265
• Device Catalogue Number: 86265
• Device Lot Number: 17E0765JZX
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 05/07/2019
• Initial Report FDA Received Date: 12/04/2018
• Supplement Report FDA Received Date: 05/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1