MAUDE Adverse Event Report: MMJ SA DE CV (USD) SHILEY; STYLET, TRACHEAL TUBE

Model Number	85863
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, there were two endotracheal tube's stylet that had cracks.There was no patient involvement.
Additional Manufacturer Narrative
D10 concomitant product: 85863, 85863 intubating stylet 6fr 2mm x20 (lot#21a0348jzx); 85863, 85863 intubating stylet 6fr 2mm x20 (lot#unknown) 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.
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.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that there were two endotracheal tube stylets that had cracks.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: shape the stylet to the configuration which will best facilitate intubation and insert into the tracheal tube.The stylet must not extend beyond the distal tip of the tracheal tube.Care should be taken not to abrade the plastic sheath on the edges of the 15 mm connector during the insertion and removal of the stylet.Extension of the stylet tip beyond the distal tip of the tracheal tube could result in tissue trauma.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: STYLET, TRACHEAL TUBE
• Manufacturer (Section D): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• Manufacturer (Section G): MMJ SA DE CV (USD); ave henequen no 1181 desarroll; ciudad juarez 32590 ; MX 32590
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19922021
• Report Number: 2936999-2024-01230
• Device Sequence Number: 18187183
• Product Code: BSR
• UDI-Device Identifier: 20884522004074
• UDI-Public: 20884522004074
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2024

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: 85863
• Device Catalogue Number: 85863
• Device Lot Number: 22H1144JZX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2024
• Supplement Date Received by Manufacturer: 09/04/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 09/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2022
• 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: PLEASE SEE NOTE ON H11
• Patient Sex: Unknown