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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; CONTAINER, I.V.
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BAXTER HEALTHCARE CORPORATION; CONTAINER, I.V. Back to Search Results
Catalog Number ASKU
Device Problem No Flow (2991)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/21/2021
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported three (3) 1000 ml evacuated containers were not holding vacuum and it was not draining fluid past 250 ml.This issue was observed during patient thoracentesis.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
The evacuated container is a sterile, nonpyrogenic, single use device used only for fluid collection and storage only.This product is not to be used for any mixing of medication, iv administration, blood collection, or diagnostic testing.The shipper label and direction insert both state for fluid and collection storage only.The user has the option to utilize another product instead.If this event were to recur it is unlikely to cause or contribute to death or serious injury.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
NI
Type of Device
CONTAINER, I.V.
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key12516465
MDR Text Key272889778
Report Number1416980-2021-05863
Device Sequence Number1
Product Code KPE
Combination Product (y/n)Y
PMA/PMN Number
NI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup
Report Date 10/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberASKU
Device Lot NumberASKU
Was Device Available for Evaluation? No
Date Manufacturer Received10/04/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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