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 customer was unable to push fluid through the line of an unspecified quantity of sub-q-set subcutaneous infusion sets.This issue occurred while attempting to flush the lines prior to patient therapy.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
H10: upon further investigation, 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: 12005645
• Report Number: 1416980-2021-03638
• Device Sequence Number: 3328427
• 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,consum
• 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: 06/15/2021
• 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