MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SUB-Q-SET SUBCUTANEOUS INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	1M8463
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the lines of five (5) subcutaneous infusion sets were plugged.It was further reported that unspecified fluid could not be flushed through the line.This issue was identified prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
H10: upon further review, it was determined that this report is a duplicate of report of 1416980-2021-03640.All investigation activities will be captured under report 1416980-2021-03640.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: SUB-Q-SET SUBCUTANEOUS INFUSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11992858
• Report Number: 1416980-2021-03619
• Device Sequence Number: 11580478
• Product Code: FPA
• UDI-Device Identifier: 00085412013480
• UDI-Public: (01)00085412013480
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K925362
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2021

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: 1M8463
• Device Lot Number: DR20D24040
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 07/23/2021
• 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: NA.