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

Catalog Number	H938901
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This event occurred between (b)(6) 2020.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that seven (7) exactamix 1500 ml dual-chamber eva bags had issues of failed or bad clamps.It was further reported that shards of plastic were breaking off when closing the clamps.This was identified during preparation of the bags, during the process of clamping the tubing after the bags were mixed.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The devices were not received for evaluation; therefore, a device analysis could not be completed.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: 10831634
• Report Number: 1416980-2020-07078
• Device Sequence Number: 2908732
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2020

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?: No
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1