MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SOLUTION ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	1C8363
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3/d10: the events occurred on unspecified dates since (b)(6) 2023.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an unspecified quantity [at least (50)] of extension sets had air.There was a significant amount of air in the filter portion of the add on set.The issues occurred during patient infusion.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
G3: correction: change aware date from may 17, 2023 (on initial report) to may 16, 2023.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.A visual inspection was performed using the naked eye which did not reveal any abnormalities that could be related to the issue.Due to the nature of the sample no further testing could be performed.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: SOLUTION ADMINISTRATION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; carretera sanchez km 18.5; parque industrial itabo, piisa; haina, san cristobal 91000 ; DR 91000
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 17089717
• Report Number: 1416980-2023-02809
• Device Sequence Number: 19541441
• Product Code: FPA
• UDI-Device Identifier: 00085412013718
• UDI-Public: (01)00085412013718
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K153158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2023

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: 1C8363
• Device Lot Number: DR22G18048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2023
• Supplement Date Received by Manufacturer: 07/13/2023
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IPILIMUMAB; NIVOLUMAB; PEMBROLIZUMAB; SECONDARY MEDICATION SET
• Patient Sex: Unknown