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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION EXTENSION SET; SET,EXTENSION,INTRAVASCULAR
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CAREFUSION EXTENSION SET; SET,EXTENSION,INTRAVASCULAR Back to Search Results
Model Number 20350E
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/30/2018
Event Type  malfunction  
Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was not sequestered for failure investigation.The root cause of this failure was not identified.Patient age/date of birth was requested but was not provided.The event reportedly occurred in a children¿s hospital; therefore it is presumed the patient was a child.
 
Event Description
The customer reported that a tpn infusion was noted have condensation, felt wet and leaked at the tubing filter.This was during patient use and did not cause harm.
 
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Brand Name
EXTENSION SET
Type of Device
SET,EXTENSION,INTRAVASCULAR
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
mustafa omar
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key8204698
MDR Text Key131712385
Report Number9616066-2018-02600
Device Sequence Number1
Product Code FPA
UDI-Device Identifier07613203012256
UDI-Public7613203012256
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K960280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 12/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/28/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number20350E
Device Catalogue Number20350E
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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