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
Additional information was added to h4 and h6.H10: 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.
Additional Manufacturer Narrative
Correction b5: upon further information/review, the reported quantity was updated to a quantity of 52 sub-q-set subcutaneous infusion sets with the reported issue (previously reported as an unspecified quantity on the initial).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: 12000004
• Report Number: 1416980-2021-03640
• Device Sequence Number: 13727862
• 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,Followup
• Report Date (Section B): 07/29/2021

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: 07/16/2021; 07/23/2021
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 07/20/2021; 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1