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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION MAXZERO NEEDLELESS CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR
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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 02/15/2018
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 attached product report states that the needleless cap cracked and leaked. There was no report of patient harm.
 
Manufacturer Narrative
Conclusion code: field left blank- no available code for undetermined or unknown cause. 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 a leak at the engagement between the top of the valve and a mated component. The root cause of the customer's report was not identified.
 
Event Description
Unexpected return - the attached product report states that the needleless cap cracked and leaked. There was no report of patient harm.
 
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Brand NameMAXZERO NEEDLELESS CONNECTOR
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key7720408
MDR Text Key115074149
Report Number9616066-2018-01114
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K132413
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
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 Received07/25/2018
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
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device? No

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