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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION EVA DUALCHAMBER CONTAINER 1.5L; CONTAINER, I.V. Back to Search Results
Catalog Number H938901
Device Problems Break (1069); Crack (1135)
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 an unspecified number of exactamix 1500 ml dual-chamber eva bag clamps would "not line up and clamp".It was further reported that when trying to close the clamps, the clamp would crack.This was identified during setup and preparation.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
H10: the device was not returned.And the lot number is unknown.Therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
EVA DUALCHAMBER CONTAINER 1.5L
Type of Device
CONTAINER, I.V.
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key11088115
MDR Text Key224762277
Report Number1416980-2020-08133
Device Sequence Number1
Product Code KPE
Combination Product (y/n)Y
PMA/PMN Number
K960581
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 01/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberH938901
Device Lot NumberASKU
Was Device Available for Evaluation? No
Date Manufacturer Received12/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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