• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION SMARTSITE NEEDLE-FREE VALVE SET, ADMINISTRATION, INTRAVASCULAR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CAREFUSION SMARTSITE NEEDLE-FREE VALVE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 2000E
Device Problems Contamination (1120); Fluid Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
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.
 
Event Description
The customer reported that when disconnecting the 5-fu pump there was a white residue found at the connection of the cadd pump to the smartsite and the amount of drug that leaked was unknown. There was no report of patient harm.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSMARTSITE NEEDLE-FREE VALVE
Type of DeviceSET, ADMINISTRATION, 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
ade ajibade
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key6443141
MDR Text Key71161743
Report Number9616066-2017-00499
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K061285
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 02/23/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2000E
Device Catalogue Number2000E
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/07/2017
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 Treatment Data
Date Received: 03/29/2017 Patient Sequence Number: 1
Treatment
CADD PUMP,CADD PUMP TUBING, TD UNK
-
-