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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION BD CONNECTA PLUS STOPCOCK; STOPCOCK, I.V. SET
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CAREFUSION BD CONNECTA PLUS STOPCOCK; STOPCOCK, I.V. SET Back to Search Results
Model Number 394910
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
No product will be returned.The customer¿s complaint could not be confirmed because the product will not be returned for failure investigation.The root cause of this failure was not identified.Although requested, patient demographics not provided.
 
Event Description
It was reported that patients flush and maintain drains at home with the use of a stopcock which occasionally leaks around the connection to the drain.When this occurs, they go to the hospital to get the stopcock changed.Although requested, there has been no further information received.
 
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Brand Name
BD CONNECTA PLUS STOPCOCK
Type of Device
STOPCOCK, I.V. SET
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer (Section G)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
Manufacturer Contact
stephen bilello
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key8489284
MDR Text Key141184479
Report Number9616066-2019-00937
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K974083
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/11/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number394910
Device Catalogue Number394910
Was Device Available for Evaluation? No
Was Device Evaluated by Manufacturer? No
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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