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

Catalog Number EMC9618

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/27/2023

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the tubing of a solution administration set separated from the drip chamber.This occurred prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information: h3, h4, h6, h10.H10: the actual device was not available; however, three photographs of the sample and two retained samples were provided for evaluation.The sample photos underwent visual inspection; however, the sample photos did not show the reported defects.The cause of the reported condition could not be determined.Visual inspection of two retention samples did not identify any abnormalities that could have contributed to the reported condition.Functional push-pull, underwater leak and air passage tests were performed; no disconnections, leaks or no blockages were identified, and no blockages were found.Traction testing was performed with no issues noted.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 SETS
• 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: 18580876
• MDR Text Key: 333739032
• Report Number: 1416980-2024-00168
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05413760141718
• UDI-Public: (01)05413760141718
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 03/05/2024

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: Health Professional
• Device Catalogue Number: EMC9618
• Device Lot Number: 23G12V261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/01/2024
• Initial Date FDA Received: 01/25/2024
• Supplement Dates Manufacturer Received: 02/12/2024
• Supplement Dates FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/12/2023
• 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