MAUDE Adverse Event Report: MEDTRONIC MEXICO PEDIATRIC BIOMEDICUS FEMORAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	96820-108
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that prior to use of the bio-medicus arterial cannulae, the customer noticed that the obturators were jammed.Scrub noticed the issue prior to handing cannula to surgeon.They tried to get it to work by soaking the cannula in warm water first.The cannulae were replaced.There were no adverse patient effects reported.
Additional Manufacturer Narrative
Device evaluation summary: visual inspection of the opened device shows the introducer appears to be deformed inside the body of both cannula.The introducer insertion force appears to be tight.Reason for return was confirmed.Conclusion: medtronic received information that prior to use of the cannulae the customer noticed that the obturators were jammed.Scrub noticed the issue prior to handing cannula to surgeon.They are trying to get it to work by soaking the cannula in warm water first since it gets stuck.The cannulae were replaced.There were no adverse patient effects reported.Complaint is confirmed for obturator not passing through the cannula.The products were not returned for analysis; however medtronic received product from additional product events where this issue was confirmed.Findings: the obturator was introduced into the cannula and it was observed that the obturator was bent and was unable to pass though the tip of the cannula.After analysis this complaint was determined to be a supplier-related issue (nordson).The manufacturing site (tijuana mexico) was notified about this and was asked to start inspection of all the product prior to release it to the field, in the meantime, nordson was contacted to help with this issue correction.It is guarantee that no more product will be released without inspection and evidence that the product performance meets specification.Review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.A review of complaints for this model number found additional complaints related to this issue, a total of 14 occurrences from 4 different customers within one month; however, as this issue has been mitigated, product manufactured on or after october should not p resent this issue.There were no adverse patient effects as a result of this incidence.Medtronic will continue to monitor for future occurrences and trends per the product quality meetings procedure.This regulatory report is being submitted as part of a retrospective review and remediation per d00953163 as part of a capa action.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PEDIATRIC BIOMEDICUS FEMORAL CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO
• Manufacturer (Section D): MEDTRONIC MEXICO; tijuana
• Manufacturer (Section G): MEDTRONIC MEXICO; tijuana
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 17285485
• Report Number: 9612164-2023-03070
• Device Sequence Number: 20386951
• Product Code: DWF
• UDI-Device Identifier: 00643169623095
• UDI-Public: 00643169623095
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K143083
• 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
• Report Date (Section B): 07/10/2023

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: 07/27/2024
• Device Model Number: 96820-108
• Device Catalogue Number: 96820-108
• Device Lot Number: 220461295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/27/2020
• 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