MAUDE Adverse Event Report: 32-IN STD BORE SET W/ MAX Y CONN; INTRAVASCULAR ADMINISTRATION SET

Model Number	MX9175
Medical Device Problem Codes	Complete Blockage (1094); Restricted Flow rate (1248)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that fluid wouldn't flow through 2 32-in std bore set w/ max y conn sets during use.The following information was provided by the initial reporter: "fluid won't flow at all".
Additional Manufacturer Narrative
Investigation summary: 3 used samples were returned for investigation by the customer.The set was examined for defects and abnormalities.No defects or abnormalities were observed.A 10 ml bd syringe filled with saline was attached to the smartsite and attempted to flush.The extension sets were unable to be flushed.Upon closer visual inspection under the microscope there was excess solvent near the female luer (part number: 1024-156-043) end of the smart site.The customer complaint that the fluid would not flow at all could be replicated for all 3 samples.The root cause is excess solvent.A device history record review for model mx9175 lot number 20056825 was performed.The search showed that a total of 14403 units in 1 lot number was built on (b)(6) 2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model mx9175 lot number 20056825 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on (b)(6) 2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that fluid wouldn't flow through 2 32-in std bore set w/ max y conn sets during use.The following information was provided by the initial reporter: "fluid won't flow at all".

• Brand Name: 32-IN STD BORE SET W/ MAX Y CONN
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12104193
• Report Number: 9616066-2021-51443
• Device Sequence Number: 19883418
• Product Code: FPA
• UDI-Device Identifier: 50885403237674
• UDI-Public: 50885403237674
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2021

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: Other
• Device Expiration Date: 05/23/2025
• Device Model Number: MX9175
• Device Catalogue Number: MX9175
• Device Lot Number: 20056825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Initial Date Received by Manufacturer: 06/04/2021
• Supplement Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 07/01/2021
• Supplement Report FDA Received Date: 09/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2020
• 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