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

Model Number	86462
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Extubate (2402)
Date of Event	08/22/2018
Type of Reportable Event	Serious Injury
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 unit's adaptor was broken.It was reported that when removing it to give surfactant, the adaptor snapped.There was no patient injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
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 unit's adaptor was broken.It was reported that when removing it to give surfactant, the adaptor snapped.A customer reported that the patient was reintubated with a replacement product.
Additional Manufacturer Narrative
One sample was received for evaluation.The reported condition was confirmed.A visual inspection was performed and it was observed the connector is broken.Device history record was reviewed and no discrepancies were found.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: 7876869
• Report Number: 2936999-2018-00579
• Device Sequence Number: 11281908
• Product Code: BTR
• UDI-Device Identifier: 60884522005468
• UDI-Public: 60884522005468
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 02/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/03/2023
• Device Model Number: 86462
• Device Catalogue Number: 86462
• Device Lot Number: 18D0080JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2018
• Initial Date Received by Manufacturer: 08/25/2018
• Supplement Date Received by Manufacturer: 09/14/2018; 12/05/2018; 01/25/2019
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 10/10/2018; 01/02/2019; 02/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention