MAUDE Adverse Event Report: MINIBORE PRESSURE RATED EXT, IV CNNCTOR; INTRAVASCULAR ADMINISTRATION SET

Model Number	MZ5301
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.Initial reporter facility name: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the minibore pressure rated ext, iv cnnctor experienced flow issues.The following information was provided by the initial reporter: nicu having issues with the maxzero connectors when infusing lipids.Getting ¿high pressure¿ alerts when infusing lipids with maxzero connectors.Also having to change out the maxzero connectors after infusing lipids due to residual left in the cap.
Additional Manufacturer Narrative
Investigation summary: no product or photo was returned by the customer.It was reported that there are issues with the maxzero connectors when infusing lipids.The customer complaint 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 mz5301 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.H3 other text : see h10.
Event or Problem Description
It was reported that the minibore pressure rated ext, iv cnnctor experienced flow issues.The following information was provided by the initial reporter: nicu having issues with the maxzero connectors when infusing lipids.Getting ¿high pressure¿ alerts when infusing lipids with maxzero connectors.Also having to change out the maxzero connectors after infusing lipids due to residual left in the cap.

• Brand Name: MINIBORE PRESSURE RATED EXT, IV CNNCTOR
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12147333
• Report Number: 9616066-2021-51494
• Device Sequence Number: 4199554
• Product Code: FPA
• UDI-Device Identifier: 50885403230545
• UDI-Public: 50885403230545
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 07/22/2021

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: MZ5301
• Device Catalogue Number: MZ5301
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/10/2021
• Supplement Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 07/09/2021
• Supplement Report FDA Received Date: 08/10/2021
• 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