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

Model Number MZ1000-07

Device Problem Contamination (1120)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: non-bd extension set; 200ml baxter bag, lot: nc126373, exp: jul21; nexterone (amiodarone hcl) premixed injection 360mg/200ml, therapy date unk.No product returned.Because no product was returned or expected to be returned, no failure investigation could be performed.The root cause of the customer's experience was not identified.

Event Description

It was reported that during a typical administration of amiodarone with an attached filter, the nurse noticed discolored sediment in the iv line near the hub of the connector.The issue was reported as iv contamination utilizing the maxzero needless connector.This occurred twice on the night shift and was noticed by the bedside nurse.The lines, iv bags and connectors were changed each time.The ".Nurse found a few 'old' connectors and utilized them for iv administration".

• 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: sylvia ventura ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 9163056
• MDR Text Key: 162026775
• Report Number: 9616066-2019-02804
• 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: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2019
• 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?: 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 Number: 1