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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INTRAVIA CONTAINER EMPTY; CONTAINER, I.V.
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BAXTER HEALTHCARE CORPORATION INTRAVIA CONTAINER EMPTY; CONTAINER, I.V. Back to Search Results
Catalog Number 2B8011
Device Problem Device Damaged Prior to Use (2284)
Patient Problem No Patient Involvement (2645)
Event Date 06/04/2020
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that two (2) intravia containers were damaged.This issues was identified when the cases were delivered.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
Additional information was added to h3 and h6.H10: the actual device was not available; however, a photograph of the sample was provided for evaluation. visual inspection of the photograph was performed using the naked eye which revealed damage on the product.Due to the nature of the sample, no additional tests were performed.The reported condition was verified.The cause of the condition could not be determined. should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
INTRAVIA CONTAINER EMPTY
Type of Device
CONTAINER, I.V.
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key10212753
MDR Text Key197141037
Report Number1416980-2020-03648
Device Sequence Number1
Product Code KPE
UDI-Device Identifier00085412003467
UDI-Public(01)00085412003467
Combination Product (y/n)Y
PMA/PMN Number
K964853
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 07/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2B8011
Device Lot NumberDR20C26062
Was Device Available for Evaluation? No
Date Manufacturer Received07/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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