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

Although requested, device has not been received.A follow up report will be submitted with failure investigation results should the device be received for evaluation.

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".

Manufacturer Narrative

Correction; section(s) brand name;device identification;medical products & therapy dates and pma/510k.No product will be returned per customer.The customer complaint could not be confirmed because the product was not sequestered or returned for failure investigation.The root cause of this failure was not identified.

Event Description

It was reported that during a typical administration of amiodarone with an attached filter, the rn 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 rn.The lines, iv bags and connectors were changed each time.The ".Nurse found a few 'old' connectors and utilized them for iv administration".Although requested, there is no additional patient or event information available.

• 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: 9164041
• MDR Text Key: 161841717
• Report Number: 9616066-2019-02791
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K132413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRI TUBING, TD UNK.