MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION MICRO-VOLUME EXTENSION SET; FILTER, INFUSION LINE

Catalog Number	2N3342
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was evaluated.Unaided visual inspection was performed and all components were correctly placed and according to specifications.Functional testing including pressure and clear passage tests were performed; no leak was found.However, a blockage was identified in the micron low volume filter component; the device was primed and the flow was not normal.The filter was disassembled to perform a closer inspection.Traces of yellow solution was found in the top membrane of the filter.No yellow solution is used during the manufacturing of the device.The cause of the yellow solution trace could not be determined; however probable cause is related to user.A batch review was conducted and there were no deviations found related to this condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
During evaluation of a non-dehp three lead extension set, the filter was found blocked resulting in abnormal flow.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: MICRO-VOLUME EXTENSION SET
• Common Device Name: FILTER, INFUSION LINE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10344854
• Report Number: 1416980-2020-04558
• Device Sequence Number: 11617220
• Product Code: FPB
• UDI-Device Identifier: 00085412004778
• UDI-Public: (01)00085412004778
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K113227
• 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): 07/30/2020

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 Catalogue Number: 2N3342
• Device Lot Number: DR19L12034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/21/2020
• Initial Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1