MAUDE Adverse Event Report: MEDTRONIC MEXICO MULTIPLE PERFUSION SET; ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPU

Model Number	14001
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: visual inspection shows a cut in one of the sections of tubing, the customer identified the location with a red mark.Performance analysis: during the cleaning process there was no leak observed from the cut.Conclusion: reason for return was confirmed.Conclusion: medtronic investigation: after investigation at medtronic , complaint is confirmed for damage to the tubing line.It is unknown what may have caused this occurrence, however, there is the possibility this was caused by the removal of the white robert's clamp.Review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.Complaints received from april 2020 through june 2021 for similar model numbers were reviewed and showed no trends warranting escalation related to this occurrence.This investigation was completed with the information that was provided, if additional information is received, this investigation will be reopened if deemed necessary.There were no adverse patient effects as a result of this incidence.Medtronic has made its supplier aware and 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.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 or Problem Description
Medtronic received information that prior to use, the customer reported the 14001 dlp multiple perfusion set had a cut in the tubing.The device was not used.There was no patient involvement so no adverse effect occurred.

• Brand Name: MULTIPLE PERFUSION SET
• Common Device Name: ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPU
• 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: 17240540
• Report Number: 9612164-2023-02923
• Device Sequence Number: 4872497
• Product Code: DTL
• UDI-Device Identifier: 00613994619693
• UDI-Public: 00613994619693
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K791498
• 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): 06/30/2023

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: 05/31/2022
• Device Model Number: 14001
• Device Catalogue Number: 14001
• Device Lot Number: 2019050584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2019
• 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