MAUDE Adverse Event Report: MEDTRONIC MEXICO CUSTOM TUBING PACK; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number HY9N98R6

Device Problem Leak/Splash (1354)

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

Event Date 11/06/2020

Event Type  malfunction  

Event Description

Medtronic received information that during use of a custom tubing pack, the customer reported that the stopcock leaked.1-2 ml of blood was lost as a result of the leak.The device was replaced to complete the procedure.There was no reported patient impact associated with this event.Additional information: there was no damage to the device packaging.There was no air noted in the system/tubing.No blood transfusion was required.

Manufacturer Narrative

Device evaluation summary: visual inspection of the stopcock shows no outward signs of physical damage or abnormalities.Pressure integrity testing was performed at 0.5 l/pm with 23 psi, (1189 mmhg) of back pressure for 10 minutes.During the pressure integrity testing there were no leaks observed from the device.Reason for return was not confirmed.Conclusion: complaint is unconfirmed for leaks in stopcock.There was no observed damage to the device and performance testing indicated that the device functions as intended.After evaluation it was determined there was no product failure that occurred during the reported event.Review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.The assemblies of the order were reviewed.Anomalies were not found in the pictures, and for the absence of information we can¿t determinate in which port of which stopcock the leak was shown.Assessment against the medtronic risk management file pfmeca document fmea0002-06 rev ac indicates that the current risk zone does not exceed the risk zone predicted in the product pfmeca.There were no adverse patient effects as a result of this incidence.Medtronic will continue to monitor for future occurrences and trends per trend analysis 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.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: CUSTOM TUBING PACK
• 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: 17125532
• MDR Text Key: 317827888
• Report Number: 9612164-2023-02589
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00763000226664
• UDI-Public: 00763000226664
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171979
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/14/2023

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 Expiration Date: 11/05/2021
• Device Model Number: HY9N98R6
• Device Catalogue Number: HY9N98R6
• Device Lot Number: 219165840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2020
• Initial Date FDA Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2020
• 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
• Patient Sex: Male