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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 Leak/Splash (1354)
Patient Problems Exposure to Body Fluids (1745); Venipuncture (2129)
Event Date 06/04/2019
Event Type  Injury  
Manufacturer Narrative
No product will be returned per customer.The customer complaint could not be confirmed because the product was not returned for failure investigation.The root cause of this failure was not identified.
 
Event Description
The reported feedback suggests that infused fluids (serum) splashed during manipulation of the connector, and an estimated 3-5 mls of serum splashed into the hcp's eyes.Due to the exposure to bodily fluids, it was reported that both the patient and the hcp were examined; the nurse however remained in medical treatment/management.No patient harm or further user harm reported.
 
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Brand Name
MAXZERO NEEDLELESS CONNECTOR
Type of Device
SET, 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
ade ajibade
10020 pacific mesa blvd
san diego, CA 92121-4386
8586172000
MDR Report Key8861185
MDR Text Key153274107
Report Number9616066-2019-02110
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 07/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMZ1000
Device Catalogue NumberMZ1000
Was Device Available for Evaluation? No
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 Sequence Number1
Patient Outcome(s) Required Intervention;
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