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

Catalog Number MRC1012P

Device Problems Fluid/Blood Leak (1250); Incomplete or Inadequate Connection (4037)

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

Event Date 10/27/2023

Event Type  malfunction  

Event Description

It was reported that a plexitron solution set experienced a connection issue which resulted in a fluid leak.This issue was further described, ¿when connected to the 3-way did not adjust (did not screw up) and sodium chloride came out¿.This issue was observed while priming the set prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

E1: initial reporter first name - (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: PLEXITRON SOLUTION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CALI; calle 36 no. 2c-22; apartado aero 2446; cali ; CO
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18467644
• MDR Text Key: 332405439
• Report Number: 1416980-2023-06991
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412654621
• UDI-Public: (01)00085412654621
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: MRC1012P
• Device Lot Number: SE22KE7
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2024
• Date Device Manufactured: 11/16/2022
• 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
• Treatment: SODIUM CHLORIDE