MAUDE Adverse Event Report: PRESSURE RATED EXT, IV CONNECTOR, NO CL; INTRAVASCULAR ADMINISTRATION SET

Model Number	MZ5305
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.Investigation summary: no product or photo was returned by the customer.The customer complaint that extension tubing backing off the catheter 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 mz5305 because a valid lot number was not provided by the customer.The root cause of this failure could not be identified without a failure investigation.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 pressure rated ext,  iv connector, no cl extension tubing separated from the iv catheter hub during use.The following information was provided by the initial reporter: "new iv extension tubing hub backed off iv catheter hub.".

• Brand Name: PRESSURE RATED EXT, IV CONNECTOR, NO CL
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12375583
• Report Number: 9616066-2021-51904
• Device Sequence Number: 4067879
• Product Code: FPA
• UDI-Device Identifier: 50885403230583
• UDI-Public: 50885403230583
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 08/02/2021

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 Model Number: MZ5305
• Device Catalogue Number: MZ5305
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 08/26/2021
• 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