MAUDE Adverse Event Report: CAREFUSION ALARIS PRESSURE RATED EXTENSION SET; SET, EXTENSION, INTRAVASCULAR

Model Number	MX5301
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the product be received for evaluation.
Event or Problem Description
It was reported from the pediatric emergency department that the pressure rated extension set leaked at the connection to the to the iv hub.

• Brand Name: ALARIS PRESSURE RATED EXTENSION SET
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9570084
• Report Number: 9616066-2020-00079
• Device Sequence Number: 381810
• Product Code: FPA
• UDI-Device Identifier: 10885403237553
• UDI-Public: 10885403237553
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/19/2019

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: 07/17/2024
• Device Model Number: MX5301
• Device Catalogue Number: MX5301
• Device Lot Number: 19076096
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1