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

Catalog Number 1C8160

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/22/2022

Event Type  malfunction  

Event Description

It was reported that two (2) cases of solution sets were incorrectly labeled.This was observed prior to use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Device manufacturer address 1: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H10: the actual devices were not available; however, a photograph of the sample was provided for evaluation.Visual inspection was performed to the photograph which observed a mix of materials.The reported condition was verified.The cause of the condition was due to a shipping 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
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; see h10; see h10; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 15447878
• MDR Text Key: 306015568
• Report Number: 1416980-2022-04906
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412020594
• UDI-Public: (01)00085412020594
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K203609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/22/2022

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
• Device Operator: Other
• Device Catalogue Number: 1C8160
• Device Lot Number: R22E05154
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/25/2022
• Initial Date FDA Received: 09/19/2022
• Supplement Dates Manufacturer Received: 10/27/2022
• Supplement Dates FDA Received: 11/22/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/06/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1