MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EUROPEAN VALVE SET, EM2400; SET, I.V. FLUID TRANSFER

Catalog Number H938724E

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/13/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a part (connector) of a em2400 valve set which connects to a total parenteral nutrition (tpn) bag came out of the rubber tubing.This occurred during bag filling.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to h3, h4, h6 and h10.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.The returned photograph was reviewed, and it was observed that the valve set connector was detached from the tubing.Due to the nature of the sample no further testing could be performed.The reported condition was verified.The cause of the condition could not be determined.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: EUROPEAN VALVE SET, EM2400
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): AVAILMED; c. industrial lt. 001 mz. 105; no 20905 int a, col cd ind.; tijuana, baja california 22444 ; MX 22444
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18178886
• MDR Text Key: 328629826
• Report Number: 1416980-2023-06068
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412475776
• UDI-Public: (01)00085412475776
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 12/20/2023

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: H938724E
• Device Lot Number: 60398457
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2023
• Initial Date FDA Received: 11/20/2023
• Supplement Dates Manufacturer Received: 12/08/2023
• Supplement Dates FDA Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/22/2022
• 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: N/A.