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

Catalog Number H938724E

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the packaging (overpouch) of a em2400 valve set was opened.This was identified before use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to h3, h4, and h6.H4: device manufactured between may 12, 2019 to may 14, 2019.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation.  visual inspection was performed to the photograph using the naked eye which revealed that the entire right side seal of the primary packaging was opened.The reported condition was verified. by the nature of the sample, no additional tests were performed. 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
• MDR Report Key: 11117780
• MDR Text Key: 225123685
• Report Number: 1416980-2020-08309
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412475776
• UDI-Public: (01)00085412475776
• Combination Product (y/n): Y
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: H938724E
• Device Lot Number: 60185854
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1