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

Catalog Number H938724E

Device Problems Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a brown packaging tape was observed on the outer plastic wrapping of an em2400 valve set.This left the outer plastic wrapping sticky.This issue was identified prior to use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The device was manufactured from april 15, 2019 - april 16, 2019.The device was received for evaluation with sections of brown sticky packaging tape on the upper and lower areas of the sealed primary packaging.Unaided visual inspection was performed which verified the reported issue.The reported condition was verified.The cause of the condition was not 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: 10184144
• MDR Text Key: 197828803
• Report Number: 1416980-2020-03514
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412475776
• UDI-Public: (01)00085412475776
• Combination Product (y/n): N
• 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: 07/20/2020

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 Expiration Date: 12/31/2021
• Device Catalogue Number: H938724E
• Device Lot Number: 60180594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Initial Date Manufacturer Received: 05/28/2020
• Initial Date FDA Received: 06/23/2020
• Supplement Dates Manufacturer Received: 07/07/2020
• Supplement Dates FDA Received: 07/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1