MAUDE Adverse Event Report: MALLINCKRODT MEDICAL MALLINCKRODT; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	110880
Medical Device Problem Codes	Leak/Splash (1354); Gas/Air Leak (2946)
Health Effect - Clinical Code	Extubate (2402)
Date of Event	12/06/2018
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, while inserted to a patient, the unit's cuff pressure decreased.Therefore, airflow was performed but the cuff pressure did not increase and air leak sound was heard during patient breathing.Replacement of tube was done, thus the patient was re-intubated.
Additional Manufacturer Narrative
Evaluation summary: one sample returned for evaluation contained in a sample bag without its original unit pack.Visual examination shows that the returned unit is contaminated.Further examination shows no other sign of any defect.The returned unit was inflated and leak tested under water.No leakage was detected.The returned unit remained inflated for a twenty four hour period and no leakage was detected.Information has been added to the database and trends will continue to be monitored.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: MALLINCKRODT
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): MALLINCKRODT MEDICAL; cornamaddy; athlone 3810
• MDR Report Key: 8608402
• Report Number: 8020889-2019-00042
• Device Sequence Number: 2010943
• Product Code: BTR
• UDI-Device Identifier: 10884521068230
• UDI-Public: 10884521068230
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K082520
• 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
• Report Date (Section B): 07/25/2019

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: 110880
• Device Catalogue Number: 110880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 07/10/2019
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 07/25/2019
• 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: Required Intervention