MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EVA DUALCHAMBER CONTAINER 1.5L; CONTAINER, I.V.

Catalog Number	H938901
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the clamps of an unspecified quantity, at least, eight (8) exactamix® 1500 ml dual-chamber eva bags were difficult to close; further described as the customer ¿had to use significant force to close the clips or they could not close them at all and had to replace them entirely¿.This was identified during setup and preparation prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
H10: thirteen (13) devices were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The clamps of the returned samples were force tested, and it was noted that the clamps had a higher closing force than expected.The reported condition was verified.The cause of the reported condition was due to a manufacturing issue.A nonconformance has been opened to address this issue.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: EVA DUALCHAMBER CONTAINER 1.5L
• Common Device Name: CONTAINER, I.V.
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10557002
• Report Number: 1416980-2020-05839
• Device Sequence Number: 14056068
• Product Code: KPE
• UDI-Device Identifier: 00085412477466
• UDI-Public: (01)00085412477466
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K960581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2020

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
• Operator of Device: Other
• Device Expiration Date: 03/04/2025
• Device Catalogue Number: H938901
• Device Lot Number: 63615-A5950
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Initial Date Received by Manufacturer: 08/25/2020
• Supplement Date Received by Manufacturer: 11/30/2020
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 12/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1