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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
Device Problem Reflux within Device (1522)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/17/2020
Event Type  malfunction  
Manufacturer Narrative
Although requested, device has not been received. A follow up report will be submitted with failure investigation results should the device be received for evaluation.
 
Event Description
The reported feedback suggests that there is continuous blood return in the needless catheters when connected to short peripheral iv catheters. There was no leakage, however the catheter remained bloody inside despite constant flushing with a pre-filled syringe of saline. The customer stated that they only use the catheters of high clinical value, such as piccs, ccic and arterial lines where there is no return of blood. They changed to a different connector for use with the short peripheral catheters.
 
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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
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 Key9968400
MDR Text Key196601966
Report Number9616066-2020-01284
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 foreign,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMZ1000
Device Catalogue NumberMZ1000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
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

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