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

Catalog Number	ACT5435
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that black particulate matter was observed in the chamber area of thirty-four (34) solution sets with duo-vent spike; this was further described as ¿black specs¿.The was observed prior use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Date returned to mfr: seventeen (17) actual samples were received for evaluation on march 19, 2021.Seventeen (17) additional actual samples were then received april 27, 2021.Thirty-four (34) actual samples were evaluated.Visual inspection with the naked eye revealed black embedded particulate matter on the chambers of a size which was within acceptable limits per product specifications.Additional gvs drip chamber visual inspection was performed and no issues noted.The returned samples meet the specification requirements.The reported condition was not verified, the samples were determined to be conforming product.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 CORPORATION; deerfield IL
• MDR Report Key: 11614156
• Report Number: 1416980-2021-01858
• Device Sequence Number: 3049759
• Product Code: FPA
• UDI-Device Identifier: 00085412079684
• UDI-Public: (01)00085412079684
• Combination Product (Y/N): Y
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K142011
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2021

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: Health Professional
• Device Catalogue Number: ACT5435
• Device Lot Number: SR20H02096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2021
• Initial Date Received by Manufacturer: 03/10/2021
• Supplement Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1