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

Model Number	18885
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	02/06/2018
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, during use of the devices, a cuff inflation/deflation issue occurred.The customer indicated that there were no patient symptoms or complications or harm associated with this event.
Additional Manufacturer Narrative
Evaluation summary: the samples were received for evaluation and no failure was confirmed.No reported event was observed in the received samples since met with the product specifications.A visual inspection was performed and it was observed all the components are assembled properly.An inflation/deflation test was performed using a syringe of air was applied to the cuffs and it was noticed the cuffs held the air, the cuffs were left inflated 2 hours, 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.
Event or Problem Description
According to the reporter, during use of the devices, a cuff inflation/deflation issue occurred.There were no patient symptoms or complications though patient had to be reintubated.

• 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: 7300068
• Report Number: 2936999-2018-00112
• Device Sequence Number: 2116747
• Product Code: BTR
• UDI-Device Identifier: 20884521032559
• UDI-Public: 20884521032559
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2019

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: 01/18/2022
• Device Model Number: 18885
• Device Catalogue Number: 18885
• Device Lot Number: 17A0354JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2019
• Initial Date Received by Manufacturer: 02/06/2018
• Supplement Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 02/27/2018
• Supplement Report FDA Received Date: 05/30/2019
• 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