MAUDE Adverse Event Report: MEDTRONIC MEXICO BIO-MEDICUS LIFE SUPPORT TM; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	LS96218-015
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that prior to use of bio-medicus life support cannulae, it was reported that the customer discovered cracks at the bottom of the cannulae.The use of the devices was unspecified.There was no patient involvement, so no adverse effect occurred.
Additional Manufacturer Narrative
Continuation of d10: concomitant product id ls96218-015 (227062397); product type: 0183-cannula; 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
Device evaluation summary: visual inspection shows evidence of damage/crack in the connector.The hemostasis cap was not returned.R eason for return was confirmed.Additional information b5.The device was replaced.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
Correction b5.Medtronic received information that prior to use of two bio-medicus life support cannulae, it was reported that the customer discovered cracks at the bottom of both cannulae.The device was replaced.There was no patient involvement, so no adverse effect occurred.Correction e.Initial reporter.(first name), (city) and (phone number): these fields were updated.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
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: BIO-MEDICUS LIFE SUPPORT TM
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 19728621
• Report Number: 9612164-2024-03214
• Device Sequence Number: 8130684
• Product Code: DWF
• UDI-Device Identifier: 00763000615413
• UDI-Public: 00763000615413
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K240534
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/29/2024

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 Expiration Date: 07/28/2026
• Device Model Number: LS96218-015
• Device Catalogue Number: LS96218-015
• Device Lot Number: 227062397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2024
• Supplement Date Received by Manufacturer: 07/15/2024; 08/20/2024; 08/14/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 08/12/2024; 08/21/2024; 08/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/28/2023
• 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