MAUDE Adverse Event Report: MEDTRONIC MEXICO BIO-MEDICUS NG ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number 96570-119

Device Problems Contamination (1120); Mechanical Problem (1384); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluation summary: visual inspection showed no outward signs of any damage.The suture collar id and the cannula od were measured using a keyence vision scope with the following suture collar id was measured to be 0.239 inches and the specification has the id to be 0.234 / 0.005 inches.Cannula od was measured to be 0.255 inches and the specification has the od to be 0.237 to 0.265 inches.Reason for return was not confirmed.Conclusion: after investigation at medtronic, complaint was unconfirmed for the suture ring being loose on the cannula body causing the device to not be fixated.There was no observed damage to the device and performance testing indicated that the device functions as intended.It is unknown what may have caused this occurrence.The device history record was not reviewed as returned product analysis found no evidence of manufacturing issues with the returned device.There were no adverse patient effects as a result of this incidence.Medtronic will continue to monitor for future occurrences and trends.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.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.

Event Description

Medtronic received information that during use of a bio-medicus nextgen femoral arterial or jugular venous cannula, the customer reported that the suture ring was loose and the cannula body was about to slip out of the patient after it was fixated under the patient's skin in particular when the patient was wet with water in the surgical field, the ring slipped easily, so there was concern whether the cannula would come off and bleeding was going to happen.The device was used to complete the procedure.There was no patient impact associated with this event.The customer stated that the suture ring during packaging was fixed in a place with a large diameter, and that this caused corrosion and decreased resistance to the main cannula unit.Medtronic received additional information stating that since it was difficult to fix it, the procedure was performed by holding it by hand to prevent the cannula from coming off.Procedure was performed holding the cannula, the suture ring was not held.

• Brand Name: BIO-MEDICUS NG ARTERIAL CANNULA
• Type of Device: 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: 17266050
• MDR Text Key: 318738997
• Report Number: 9612164-2023-03027
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K142673
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/06/2023

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
• Device Operator: Health Professional
• Device Model Number: 96570-119
• Device Catalogue Number: 96570-119
• Device Lot Number: 222649386
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2022
• Initial Date FDA Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1