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

Catalog Number	1C8363
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
During evaluation of a returned unused 0.22 micron extension set, the set was found to have a cut in the sterile packaging.No additional information is available.
Additional Manufacturer Narrative
The device was received for evaluation.Visual inspections revealed there was a cut in the packaging.The most likely cause of the condition was determined to be an issue with the operator of the device slicing open the packaging after manufacturing.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: 16658446
• Report Number: 1416980-2023-01463
• Device Sequence Number: 7237626
• 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
• Report Date (Section B): 03/31/2023

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: DR21H18017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 03/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2021
• 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