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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 Fluid Leak (1250)
Patient Problem Underdose (2542)
Event Date 02/12/2020
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: used 2. 5ml covidien monoject syringe, lot: 19i1124, exp: 2021-08-31, 0. 9% sodium chloride; non-bd extension set; td (b)(6) 2020. 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
It was reported that there was a leak between the maxzero and a non-bd syringe. The event occurred in the cvicu. It was reported that patient did not receive the full dose of antibiotic as a result. There was no patient or user harm. The event did not cause a delay that significantly impacted patient outcome. Although requested, no patient information provided.
 
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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 Key9856766
MDR Text Key188882414
Report Number9616066-2020-00825
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,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/20/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberMZ1000-07
Device Catalogue NumberMZ1000-07
Device Lot Number19107081
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/09/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/26/2019
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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