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 MZ1000-07
Device Problem Failure to Disconnect (2541)
Patient Problem No Code Available (3191)
Event Date 06/28/2018
Event Type  Injury  
Manufacturer Narrative
The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.
 
Event Description
The customer reported that 5 days after the product was placed on the bard 5fr powerpicc, they tried removing it using multiple methods, but were unsuccessful.The picc was being used for tpn and fluids.The patient had to have the picc line removed and a new one placed.
 
Manufacturer Narrative
The customer¿s report of being unable to disconnect the valve from the picc line was confirmed.Inspection of the received sample confirmed it was unable to be disconnected at the connection between the picc female luer and the maxzero male end.Tool marks were observed at the connection.Attempts to disconnect the mating components were not successful.After many unsuccessful attempts to disconnect by hand, lab pliers were used to disconnect the mating components.Once disconnected the mating components were re-examined, showing an unknown hardened substance on both of the mating components.Testing was not able to identify the substance.The root cause of the customer's experience was not determined.
 
Event Description
The customer reported that 5 days after the product was placed on the bard 5fr powerpicc, they tried removing it using multiple methods, but were unsuccessful.The picc was being used for tpn and fluids.The patient had to have the picc line removed and a new one placed.
 
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 Key7740723
MDR Text Key115737240
Report Number9616066-2018-01158
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10885403230196
UDI-Public10885403230196
Combination Product (y/n)N
PMA/PMN Number
K132413
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Type of Report Initial,Followup
Report Date 07/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/01/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMZ1000-07
Device Catalogue NumberMZ1000-07
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/24/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
PICC, THERAPY DATE (B)(6) 2018; PICC, THERAPY DATE (B)(6) 2018
Patient Outcome(s) Required Intervention;
Patient Weight24
-
-