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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 Problem High Test Results (2457)
Patient Problems Therapeutic Effects, Unexpected (2099); Therapeutic Response, Increased (2272)
Event Type  malfunction  
Manufacturer Narrative
Although requested, device has not been received, and patient demographic details were not provided. Patient is a child. A follow up report will be submitted with failure investigation results should the device be received for evaluation.
 
Event Description
It was reported that after a child's blood draw through the maxzero, the ptt lab results were too high. No other results were skewed. No patient harm occurred and no other patient effects were noted.
 
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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 Key8619222
MDR Text Key145384459
Report Number9616066-2019-01275
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 health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/18/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/17/2019
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? No
Is the Reporter a Health Professional? Yes
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

Patient Treatment Data
Date Received: 05/17/2019 Patient Sequence Number: 1
Treatment
8110,8015,SYR TUBING, TD UNK
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