MAUDE Adverse Event Report: MICROBORE EXTENSION SET, IV CONNECTOR, T; INTRAVASCULAR ADMINISTRATION SET

Model Number	MZXT9001
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: a complaint of a component coming loose and the set leaking was received from the customer.No product or photo was returned by the customer.The customer complaint of loose component could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model mzxt9001 because a lot number was not provided by the customer.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.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 the microbore extension set, iv connector, t came loose from the maxzero tubing during use and leaked contrast.The following information was provided by the initial reporter: "so what is happening is the maxzero tubing that is already on the patient is being connected to the contrast tubing and then starts the process for the contrast which is then at times the connection comes loose and contrast leaks out.".

• Brand Name: MICROBORE EXTENSION SET, IV CONNECTOR, T
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12413948
• Report Number: 9616066-2021-51939
• Device Sequence Number: 11644714
• Product Code: FPA
• UDI-Device Identifier: 50885403240803
• UDI-Public: 50885403240803
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2021

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 Model Number: MZXT9001
• Device Catalogue Number: MZXT9001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2021
• Initial Report FDA Received Date: 09/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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