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

Model Number	18775
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/23/2018
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 unit had cuff inflation/deflation issue.They used a syringe to push air in and out of the cuff.The customer indicated that there was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary: one sample was received for evaluation.The reported condition was confirmed.An inflation deflation test was performed and it was observed the cuff inflated, at the time of deflation a restriction was observed.A visual inspection was performed and it was observed the pilot balloon collapses over the inflation line.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: 8196601
• Report Number: 2936999-2018-00791
• Device Sequence Number: 11185848
• Product Code: BTR
• UDI-Device Identifier: 60884522007608
• UDI-Public: 60884522007608
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K090352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2019

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: 11/15/2021
• Device Model Number: 18775
• Device Catalogue Number: 18775
• Device Lot Number: 16K0437JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Initial Date Received by Manufacturer: 11/29/2018
• Supplement Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 12/26/2018
• Supplement Report FDA Received Date: 08/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1