MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION MICRO-VOLUME RADIATION STERILIZED EXTENSION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2N3348
Medical Device Problem Codes	Partial Blockage (1065); No Flow (2991)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred during the unspecified date of (b)(6) 2019.The user facility submitted a medwatch report for this event: uf/importer report # (b)(4).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that two (2) non-dehp micro-volume extension sets would not flush as though there was an occlusion in the tubing.This was identified while attempting to set up an infusion.There was no patient involvement.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.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.

• Brand Name: MICRO-VOLUME RADIATION STERILIZED EXTENSION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9650166
• Report Number: 1416980-2020-00307
• Device Sequence Number: 19530794
• Product Code: FPA
• UDI-Device Identifier: 00085412004822
• UDI-Public: (01)00085412004822
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K811078
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2020

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: 2N3348
• Device Lot Number: UR19I07013
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/06/2020
• Supplement Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 02/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1