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

Model Number	86453
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Information (3190)
Date of Event	02/04/2019
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, the device had a leak and the cuff would not stay inflated.There was no reported patient involvement or outcome.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted that the cuff presents a tear.It was reported that the device had a leak and the cuff would not stay inflated.The reported issues were confirmed.The most likely cause was traced to component failure.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.The instructions included with this device provide the following guidance: as these devices may have been subjected to handling, storage conditions or preparation which compromised functional integrity; each tube' cuff, pilot balloon and valve should be tested by inflation prior to use.If dysfunction is detected in any part of the inflation system, the tube should not be used.Initiating treatment using a tube already shown to have a dysfunction in the inflation system could unnecessarily subject the patient to the untoward effects of extubation, re-intubation, or loss of respiratory support.Furthermore, the integrity of the inflation system should be monitored both initially and periodically during the intubation period.Uncorrected failure of the inflation system could result in death.Various bony anatomical structures (e.G., teeth, turbinates) within the intubation routes or any intubation tools with sharp surfaces present a threat to maintaining cuff integrity.Care must be taken to avoid damaging the thin-walled cuffs during insertion which would create the need to subject the patient to the trauma of extubation and re-intubation.If the cuff is damaged, the tube should not be used.Do not overinflate cuff.Ordinarily, the cuff pressure should not exceed 25 cm h20.Carroll and grenvik recommend maintaining a seal pressure at or below 25 cm h20 (carroll, r.G., and grenvik, a.: proper use of large diameter, large residual cuffs.Critical care medicine vol.1, no.3:153-154, 1973).Overinflation can result in tracheal damage, rupture of the cuff with subsequent deflation, or in cuff distortion which may lead to airway blockage.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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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: 8381889
• Report Number: 2936999-2019-00155
• Device Sequence Number: 19145829
• Product Code: BTR
• UDI-Device Identifier: 60884522000494
• UDI-Public: 60884522000494
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K965132
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/27/2021

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 Model Number: 86453
• Device Catalogue Number: 86453
• Device Lot Number: 18B0020J
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Initial Date Received by Manufacturer: 02/06/2019
• Supplement Date Received by Manufacturer: 03/14/2019; 05/30/2019
• Initial Report FDA Received Date: 03/01/2019
• Supplement Report FDA Received Date: 04/04/2019; 01/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1