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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION STOPCOCK; STOPCOCK, I.V. SET
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BAXTER HEALTHCARE CORPORATION STOPCOCK; STOPCOCK, I.V. SET Back to Search Results
Catalog Number 2C6204
Device Problem No Flow (2991)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/18/2021
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported a large bore stopcock would not flow; further described as the stopcock did not let saline flow in the line.It was further stated that the iv was unable to be flushed through the sidearm of the stopcock.This issue was identified during patient infusion.There was no patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was discarded; 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
STOPCOCK
Type of Device
STOPCOCK, I.V. SET
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key12253238
MDR Text Key264311404
Report Number1416980-2021-04674
Device Sequence Number1
Product Code FMG
UDI-Device Identifier00085412001913
UDI-Public(01)00085412001913
Combination Product (y/n)Y
PMA/PMN Number
K130245
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/31/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2C6204
Device Lot NumberUR21C15031
Was Device Available for Evaluation? No
Date Manufacturer Received08/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NI.
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