MAUDE Adverse Event Report: 40 INCH EXT W/2 VLV PORTS; INTRAVASCULAR ADMINISTRATION SET

Model Number	30263E
Medical Device Problem Codes	Backflow (1064); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: one sample was returned for investigation by the customer.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The sample was primed with saline.A bd secondary set was primed with blue dye and attached to the returned sample.Both sets were allowed to free flow.No backflow was observed.The customer complaint that the tubing had allowed backflow of blood when in use could not be replicated.The root cause could not be determined because the issue could not be replicated.A device history record review for the model lot number was performed.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 40 inch ext w/2 vlv ports allowed backflow of blood.The following information was provided by the initial reporter: "on friday, july 9, i received a call from anesthsia about iv tubing that had allowed blood to back up and come out of one of the access ports.".

• Brand Name: 40 INCH EXT W/2 VLV PORTS
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12294186
• Report Number: 9616066-2021-51739
• Device Sequence Number: 11714000
• Product Code: FPA
• UDI-Device Identifier: 50885403235205
• UDI-Public: 50885403235205
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/13/2021

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: Health Professional
• Device Expiration Date: 09/04/2023
• Device Model Number: 30263E
• Device Catalogue Number: 30263E
• Device Lot Number: 20099520
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2021
• Initial Report FDA Received Date: 08/09/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2020
• 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