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

Catalog Number H938724E

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The event was observed on an unspecified date of (b)(6) 2019.Lot manufactured between may 11, 2018 to may 13, 2018.The actual devices were not available; however, photographs of the samples were provided for evaluation. visual inspection of the photographs using the naked eye revealed incomplete or missing seal on the side of the alleged two (2) samples.By the nature of the sample, no additional tests were 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.

Event Description

It was reported that the primary packaging of two (2) em2400 valve sets were defective.The defect was further describe as "defective peel seam" (opened).This issue was identified before use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The device was manufactured from may 11, 2018 - may 13, 2018.The two (2) actual samples were received for evaluation.Visual inspection was performed which observed that the primary packaging seal had an opened section on the right side of both samples.The reported problem 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 ¿ ROUND LAKE; round lake IL
• MDR Report Key: 9200414
• MDR Text Key: 162823438
• Report Number: 1416980-2019-05655
• 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: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2021
• Device Catalogue Number: H938724E
• Device Lot Number: 60125789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2019
• Date Manufacturer Received: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1