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

Catalog Number	1C8363
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
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 four (4) extension sets were found with particles in the packaging.This was discovered prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Correction made to d4: lot #: dr22k11017 previously submitted as asku.Correction made to d4: unique identifier (udi) #: (b)(4) previously submitted as ni.H10: four (4) actual devices were received for evaluation.A visual inspection was performed using the naked eye and all components were observed correctly placed and according to specifications.A small brown particulate was observed inside of the packaging, but not inside of the product itself.The reported condition was verified.The cause of the condition could not be determined.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: 17958654
• Report Number: 1416980-2023-05297
• Device Sequence Number: 5033847
• Product Code: FPA
• UDI-Device Identifier: 00085412013718
• UDI-Public: (01)00085412013718
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2023

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: Other
• Device Catalogue Number: 1C8363
• Device Lot Number: DR22K11017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2023
• Supplement Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 10/18/2023
• Supplement Report FDA Received Date: 12/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Patient Sex: Unknown