Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CAREFUSION MAXZERO NEEDLELESS CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CAREFUSION MAXZERO NEEDLELESS CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number MZ1000
Device Problems Fluid/Blood Leak (1250); Fracture (1260)
Patient Problems Extravasation (1842); No Consequences Or Impact To Patient (2199)
Event Date 04/24/2019
Event Type  malfunction  
Manufacturer Narrative
Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.
 
Event Description
Feedback suggests that there was an extravasation injury.The customer reported that the piston had folds and torsion when connected to with syringes and after infusion extravasation was identified.
 
Event Description
After further investigation and clarification with the affiliate, it has been determined that the original report was incorrect.The extravasation incident report has been retracted.The actual confirmed event does involve the ¿piston¿ of the maxzero, but was a leak due to a stick down of the piston involving ¿splashing¿ or leakage from the maxzero when the syringe was removed.No patient or user harm in this incident.
 
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
MAXZERO NEEDLELESS CONNECTOR
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
CAREFUSION
10020 pacific mesa blvd
san diego CA 92121 4386
MDR Report Key8826824
MDR Text Key152209586
Report Number9616066-2019-02045
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Type of Report Initial,Followup
Report Date 04/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMZ1000
Device Catalogue NumberMZ1000
Device Lot Number17095909
Was Device Available for Evaluation? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-