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

Model Number	18870
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Extubate (2402)
Date of Event	04/01/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
Medtronic received a report the cuff on the tracheal tube ruptured.Medtronic is requesting additional information regarding the circumstances of the event.
Additional Manufacturer Narrative
Evaluation summary: the sample was received for analysis and the reported issue was confirmed.The reported customer event is a known issue and root cause investigation efforts have been addressed in a corrective and preventative action.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during use, the taperguard has a rupture tube.There was no patient injury.

• 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: 6652507
• Report Number: 2936999-2017-05272
• Device Sequence Number: 13779477
• Product Code: BTR
• UDI-Device Identifier: 30884521032525
• UDI-Public: 30884521032525
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K090352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2018

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: 04/22/2019
• Device Model Number: 18870
• Device Catalogue Number: 18870
• Device Lot Number: 14D0717JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Initial Date Received by Manufacturer: 05/23/2017
• Supplement Date Received by Manufacturer: 07/27/2018
• Initial Report FDA Received Date: 06/19/2017
• Supplement Report FDA Received Date: 08/22/2018
• 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