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

Catalog Number	1C8296
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2020
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 packaging of an unspecific quantity of solution sets were damaged.This issue was identified during setup and preparation prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
H10: the actual device was not available.However, a photograph of the sample was provided for evaluation.Visual inspection of the photograph was performed, which observed damage to the packaging.The reported condition was verified.The cause of the condition was, due to a transportation/distribution issue.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 SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11399454
• Report Number: 1416980-2021-00984
• Device Sequence Number: 2191037
• Product Code: FPA
• UDI-Device Identifier: 00085412021157
• UDI-Public: (01)00085412021157
• Combination Product (Y/N): Y
• Initial Reporter Country: US
• PMA/510(K) Number: K961225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2021

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: Other
• Device Catalogue Number: 1C8296
• Device Lot Number: DR19K25046
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/05/2021
• Supplement Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 03/02/2021
• Supplement Report FDA Received Date: 03/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1