MAUDE Adverse Event Report: MEDTRONIC MEXICO S. DE R.L. DE CV CUSTOM TUBING PACK; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	BB10Z49R21
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Continuation of d10: product id bb10z49r21 (231349285); product type: 0186-custom tubing packs; implant date n/a; explant date n/a product id bb10z49r21 (231349285); product type: 0186-custom tubing packs; implant date n/a; explant date n/a 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
Medtronic received information that prior to use of 3 custom packs, it was reported all 3 packs were damaged, and this affected the outer packaging, inner packaging, and also the sterile barrier.All 3 device were not used, and was replaced to complete the case.There was no patient involvement, so no adverse effect occurred.
Additional Manufacturer Narrative
Correction b5: medtronic received information that prior to use of 3 custom tubing packs, it was reported all 3 packs were damaged, and this affected the outer packaging, inner packaging, and also the sterile barrier.All 3 devices were not used, and were replaced.There was no patient involvement, so no adverse effect occurred.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: CUSTOM TUBING PACK
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO
• 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: 23826828
• Report Number: 9617601-2025-03547
• Device Sequence Number: 14722583
• Product Code: DWF
• UDI-Device Identifier: 00199150021048
• UDI-Public: (01)00199150021048(17)270205(10)231349285
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K171979
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2026

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 Model Number: BB10Z49R21
• Device Catalogue Number: BB10Z49R21
• Device Lot Number: 231349285
• 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: 12/15/2025
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 03/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/24/2025
• 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