MAUDE Adverse Event Report: COVIDIEN AG JUAREZ (MMJ) SHILEY; TUBE, TRACHEAL (W/WO CONNECTOR)

Model Number	86111-
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D10 concomitant product: 355/5430z - 355/5430z jp hygroboy elecst fhme x25 (lot#23g0162fax).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
According to the reporter, prior to use, the co2 sampling port of the filter was damaged, and it was replaced with a new one.It was also reported that the cuff of the endotracheal tube did not inflate.There was no patient involvement.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the inflation line tubing was collapsed inside the lumen of the tube.Functionally, an inflation/deflation test was performed.Air was applied to the cuff using a syringe, and it was observed that inflation was difficult and deflation was hard.It was reported that the co2 sampling port of the filter was damaged and the cuff of the endotracheal tube did not inflate.The reported issues were confirmed.The most likely cause was determined to be manufacturing related.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¿s 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 h2o.Carroll and grenvik recommend maintaining a seal pressure at or below 25 cm h2o (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 submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: SHILEY
• Common Device Name: TUBE, TRACHEAL (W/WO CONNECTOR)
• Manufacturer (Section D): COVIDIEN AG JUAREZ (MMJ); 1181 hennequen ave.; juarez,chi 32575 ; MX 32575
• Manufacturer (Section G): COVIDIEN AG JUAREZ (MMJ); 1181 hennequen ave.; juarez,chi 32575 ; MX 32575
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 20863240
• Report Number: 9681384-2024-00210
• Device Sequence Number: 8839308
• Product Code: BTR
• UDI-Device Identifier: 10884522000116
• UDI-Public: 10884522000116
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K871204
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2025

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: 86111-
• Device Catalogue Number: 86111-
• Device Lot Number: 24F0257JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Patient Sex: Unknown