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

MAUDE Adverse Event Report: CAREFUSION MAXZERO NEEDLELESS CONNECTOR 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 MAXZERO NEEDLELESS CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MZ1000-07
Device Problems Fluid Leak (1250); Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/05/2017
Event Type  malfunction  
Manufacturer Narrative
The devices have been received and the evaluation is pending. A follow up report will be submitted with investigation results once the evaluation has been completed.
 
Event Description
Unexpected return; the product report from the customer states that doxorubicin leaked from the connection of the administration set to the maxzero. Upon inspection, a crack was found in the maxzero. There was no report of patient harm.
 
Manufacturer Narrative
The customer report that the maxzero valve leaked and had a crack was confirmed. Visual inspection showed a crack running along one side of the top of the valve. Functional testing showed that fluid leaked from the engagement between the syringe and the valve. The root cause of the customer's report was not identified.
 
Event Description
Unexpected return - the product report from the customer states that doxorubicin leaked from the connection of the administration set to the maxzero. Upon inspection, a crack was found in the maxzero. There was no report of patient harm.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameMAXZERO NEEDLELESS CONNECTOR
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
mustafa omar
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key7708912
MDR Text Key114685095
Report Number9616066-2018-01117
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132413
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMZ1000-07
Device Catalogue NumberMZ1000-07
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/28/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-