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

Catalog Number AMC9607C

Device Problem Component Misassembled (4004)

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

Event Date 01/25/2024

Event Type  malfunction  

Event Description

It was reported that the blue clamp of a light sensitive drug set was found to be in an inverted position.This occurred during patient use.The device was used for premedication for chemotherapy.The equipment was changed to complete the procedure.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

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

Manufacturer Narrative

Correction: f10/h6: component codes (replace g04109 with g0405203).H10: the actual device was not available; however, three (3) retained samples were provided for evaluation.Visual inspection of the samples did not identify any abnormalities that could have contributed to the reported condition; the blue slide clamps were assembled in the correct position.The reported condition was not verified on the retained samples.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 - MALTA; a47 industrial estate; marsa ; MT
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18812800
• MDR Text Key: 336629472
• Report Number: 1416980-2024-00849
• Device Sequence Number: 1
• Product Code: FPA
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: AMC9607C
• Device Lot Number: 23I05V899
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/07/2023
• 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
• Patient Age: 32 YR
• Patient Sex: Female