MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV AUTOLOG ONE SOURCE PACK; APPARATUS, AUTOTRANSFUSION

Model Number	ATLS24
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that prior to use of autolog one source packs, it was reported that there were only 2 layers of packaging when there should be 3 layers to guarantee sterilization.The device was replaced.There was no patient involvement, so no adverse effect occurred.Medtronic received additional information that there were 14 products.All packed in the wrong way so they were not sterile upon arrival.Medtronic received additional information that these where already replaced and shipped to customer, however the new products that where sent as replacements were also sent with two layers.
Additional Manufacturer Narrative
This regulatory report is being submitted as part of a retrospective review and remediation as part of a capa action.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: AUTOLOG ONE SOURCE PACK
• Common Device Name: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer (Section G): MEDTRONIC MEXICO S. DE R.L. DE CV; av. paseo del cucapah #10510; tijuana,bc 22210 ; MX 22210
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 24108713
• Report Number: 9617601-2026-00353
• Device Sequence Number: 5816477
• Product Code: CAC
• UDI-Device Identifier: 00643169108363
• UDI-Public: (01)00643169108363(17)250501(10)0227204851
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K093535
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 01/19/2026

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 Expiration Date: 05/01/2025
• Device Model Number: ATLS24
• Device Catalogue Number: ATLS24
• Device Lot Number: 0227204851
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2023
• 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
• Patient Sex: Unknown