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

Model Number	18880
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Information (3190)
Date of Event	06/08/2018
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 of the device, there was voice leakage soon after intubation and the cuff was found broken.There was no patient injury.
Additional Manufacturer Narrative
The incident device has been received and is under evaluation.When the device evaluation is complete a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during use of the device, there was voice leakage soon after intubation and the cuff was found broken.
Additional Manufacturer Narrative
Evaluation summary: one sample of device was received for evaluation.An inflation/deflation test was performed.A visual inspection was performed, and it was observed the cuff presents a small tear.The investigation of observed condition isolated the failure to the tear on the cuff.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: 7634035
• Report Number: 2936999-2018-00411
• Device Sequence Number: 19271158
• Product Code: BTR
• UDI-Device Identifier: 30884521032549
• UDI-Public: 30884521032549
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/28/2019

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 Model Number: 18880
• Device Catalogue Number: 18880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Initial Date Received by Manufacturer: 06/08/2018
• Supplement Date Received by Manufacturer: 08/21/2018; 02/04/2019
• Initial Report FDA Received Date: 06/25/2018
• Supplement Report FDA Received Date: 09/19/2018; 02/28/2019
• 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: Other