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

Model Number	MZ9325
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was not sequestered for failure investigation.The root cause of this failure was not identified.
Event or Problem Description
Customer advocacy received a copy of the customer's medwatch report from the fda which states, "carefusion microbore tri-fuse extension set with filter noted to be leaking." an incomplete date of event of (b)(6) 2019 was provided.
Event or Problem Description
Customer advocacy received a copy of the customer's medwatch report from the fda which states, "carefusion microbore tri-fuse extension set with filter noted to be leaking." an incomplete date of event of (b)(6) 2019 was provided.

• Brand Name: ALARIS EXTENSION SET
• Common Device Name: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9868131
• Report Number: 9616066-2020-01080
• Device Sequence Number: 11523266
• Product Code: FPA
• UDI-Device Identifier: 10885403427244
• UDI-Public: 10885403427244
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2020

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: MZ9325
• Device Catalogue Number: MZ9325
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/23/2020
• Supplement Report FDA Received Date: 06/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PRI TUBING, THERAPY DATE UNK; THERAPY DATE (B)(6) 2019
• Patient Age: 10 DA
• Patient Weight: 1