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

Catalog Number EMC9618

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was a hole at the tube under the drip chamber of five (5) solution administration sets that resulted in a leak.The issue was identified during filling.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to d4 (expiration date), d9, h3, h4, h6 and h10.H10: two (2) actual samples were received for evaluation; the other three (3) samples were not received and therefore, could not be evaluated.A visual inspection was performed which revealed the tube was incorrectly assembled to the drip chamber (the tube was not inserted over the chamber pipe).The reported condition was verified.The cause of the condition was an incorrect insertion of the tube onto the chamber pipe during the automated assembly process.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: 18021974
• MDR Text Key: 326740157
• Report Number: 1416980-2023-05512
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• 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: 23D08V160
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2023
• 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
• Treatment: N/A.