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

Model Number	18750
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/26/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received a report regarding an endotracheal tube.The customer reported that during the pre-test, the cuff would not deflate completely.There was no patient involvement.
Additional Manufacturer Narrative
The event was escalated for formal investigation consideration and it was concluded that based on the risk analysis, no formal investigation is required.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report regarding an endotracheal tube.The customer reported that during the pre-test, the cuff would not deflate completely.There was no patient involvement.
Additional Manufacturer Narrative
The sample was received for analysis and the reported issue was confirmed.A inflation/deflation test was performed and it was observed the cuff deflated after seconds.A visual inspection was performed and it was observed the distal end of the tube had an open lumen.The device history record (dhr) was reviewed and no discrepancies related to the failure mode were found.An investigation has been initiated at the manufacturing facility, but has not yet provided evaluation conclusions.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received a report regarding an endotracheal tube.The customer reported that during the pre-test, the cuff would not deflate completely.There was no patient involvement.

• 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: 6595861
• Report Number: 2936999-2017-05226
• Device Sequence Number: 760539
• Product Code: BTR
• UDI-Device Identifier: 30884522007539
• UDI-Public: 30884522007539
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/19/2017

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: 03/03/2021
• Device Model Number: 18750
• Device Catalogue Number: 18750
• Device Lot Number: 16C0164JZX
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/24/2017
• Initial Date Received by Manufacturer: 05/02/2017
• Supplement Date Received by Manufacturer: 08/24/2017; 09/19/2017
• Initial Report FDA Received Date: 05/26/2017
• Supplement Report FDA Received Date: 09/19/2017; 10/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1