MAUDE Adverse Event Report: BAXTER HEALTHCARE - CARTAGO DUO-VENT SOLUTION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	ACT5439
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a duo-vent solution set had particulate matter when being used to administer an unspecified solution.This was observed during an unspecified process step.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information : a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: DUO-VENT SOLUTION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - CARTAGO; cartago
• MDR Report Key: 8227921
• Report Number: 1416980-2018-08240
• Device Sequence Number: 2112010
• Product Code: FPA
• UDI-Device Identifier: 00085412079691
• UDI-Public: (01)00085412079691
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K142011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2019

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: Other
• Device Expiration Date: 06/21/2023
• Device Catalogue Number: ACT5439
• Device Lot Number: R18F21102
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/14/2018
• Supplement Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 01/08/2019
• Supplement Report FDA Received Date: 02/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1