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

Model Number	18775
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/06/2018
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, during cuff test, the inflated cuff leaked air.The customer indicated that there was no patient involved in this event.
Additional Manufacturer Narrative
(first name, last name, email address), (phone#).Evaluation summary: without the actual complaint sample a full investigation cannot be carried out therefore we are unable to determine the cause for this specific event.Manufacturing controls were found acceptable and effective to detect the reported failure mode.An inflation/deflation was perform and the operator inspects for no leaks and segregates the defective parts.Device history records were reviewed and no discrepancies were found.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.; ave. henequen no 1181 desarrol; ciudad juarez,ci 32590 ; MX 32590
• MDR Report Key: 7305971
• Report Number: 2936999-2018-00124
• Device Sequence Number: 957438
• Product Code: BTR
• UDI-Device Identifier: 60884522007608
• UDI-Public: 60884522007608
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K090352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2018

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: 03/06/2022
• Device Model Number: 18775
• Device Catalogue Number: 18775
• Device Lot Number: 17C0328JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Initial Date Received by Manufacturer: 02/13/2018
• Supplement Date Received by Manufacturer: 08/01/2018
• Initial Report FDA Received Date: 03/01/2018
• Supplement Report FDA Received Date: 08/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1