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

Model Number MZ1000-07

Device Problem Fluid/Blood Leak (1250)

Patient Problems Underdose (2542); No Information (3190)

Event Date 07/14/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: 3ml bd syringe; non-bd extension set; 2.5ml monoject syringe; td (b)(6) 2019.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 in the cardiovascular icu, the tubing leaked iv lasix at the connection with the needleless valve.It is unknown if the patient received the full dose of lasix.

Event Description

It was reported that in the cardiovascular icu, the tubing leaked iv lasix at the connection with the needleless valve.It is unknown if the patient received the full dose of lasix.

Manufacturer Narrative

The customer report of a leak at the connection with the needleless valve was confirmed.Visual inspection showed no anomalies.No obvious issues were observed with the received samples.Testing was performed on the as-received 3ml syringe and mz1000-07.The attached components, with air in syringe, were submerged underwater and when the syringe plunger was depressed, a leak was observed at the engagement between the two components.The components were detached from each other and inspection of the mated components observed no obvious damages or issues.The root cause was identified as due to a damaged syringe luer tip.

• 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 Key: 8938742
• MDR Text Key: 155833217
• Report Number: 9616066-2019-02388
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403230196
• UDI-Public: 10885403230196
• Combination Product (y/n): N
• PMA/PMN Number: K132413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 07/31/2019

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 Expiration Date: 04/02/2021
• Device Model Number: MZ1000-07
• Device Catalogue Number: MZ1000-07
• Device Lot Number: 18045157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 10014914, TD 01/01/2019.; 10014914, TD (B)(6) 2019