MAUDE Adverse Event Report: MMJ, S.A. DE C.V.(USD) MALLINCKRODT; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	86112
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	04/05/2018
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, the device's cuff did not inflate when an air was pushed.The customer indicated that the patient had to be re-cannulated with a new tube.
Additional Manufacturer Narrative
Evaluation summary: one sample was received for analysis and the reported issue could not be confirmed.A visual inspection was performed and it was observed all the components are assembled properly at the tube.An inflation/deflation test was performed using a syringe 25cc of air was applied to the cuff and it was observed the cuff held the air, the sample was left inflated 2 hours according to process instruction and after this time no deflation was observed.The sample was submerged into a container filled with water and no leaks were observed.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, S.A. DE C.V.(USD); ave. henequen no 1181 desarrol; ciudad juarez,ci 32590 ; MX 32590
• MDR Report Key: 7443617
• Report Number: 2936999-2018-00274
• Device Sequence Number: 13966338
• Product Code: BTR
• UDI-Device Identifier: 60884522000128
• UDI-Public: 60884522000128
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K871204
• 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): 09/04/2018

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: 01/09/2022
• Device Model Number: 86112
• Device Catalogue Number: 86112
• Device Lot Number: 17A0180JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2018
• Initial Date Received by Manufacturer: 04/05/2018
• Supplement Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 04/19/2018
• Supplement Report FDA Received Date: 09/04/2018
• 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