MAUDE Adverse Event Report: CAREFUSION MAXZERO NEEDLELESS CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MZ1000-07

Device Problems Fluid/Blood Leak (1250); Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/05/2017

Event Type  malfunction  

Manufacturer Narrative

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

Unexpected return; the product report from the customer states that doxorubicin leaked from the connection of the administration set to the maxzero.Upon inspection, a crack was found in the maxzero.There was no report of patient harm.

Manufacturer Narrative

The customer report that the maxzero valve leaked and had a crack was confirmed.Visual inspection showed a crack running along one side of the top of the valve.Functional testing showed that fluid leaked from the engagement between the syringe and the valve.The root cause of the customer's report was not identified.

Event Description

Unexpected return - the product report from the customer states that doxorubicin leaked from the connection of the administration set to the maxzero.Upon inspection, a crack was found in the maxzero.There was no report of patient harm.

• 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: mustafa omar ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 7708912
• MDR Text Key: 114685095
• Report Number: 9616066-2018-01117
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403230196
• UDI-Public: 10885403230196
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MZ1000-07
• Device Catalogue Number: MZ1000-07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/21/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1