MAUDE Adverse Event Report: CAREFUSION MAXZERO NEEDLELESS CONNECTOR; SET, EXTENSION, 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.The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.

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

The customer¿s report of contamination was confirmed based on visual inspection and analysis of the observed sediments within the non-bd extension set and maxzero components.Visual inspection of the as-received samples observed dark-colored sediment within both the extension set and maxzero.No other issues were observed.The observed sediments were not observed to be within the primary set.Ftir analysis was not 100% conclusive in identifying the sediments.The highest matches were of cohesive tape in which the material is made of cellulose and lignin.The samples were received attached to each other: infusion bag to primary set's drip chamber spike.Set's male luer to extension set.Extension set's male luer to maxzero.Alcohol caps to both smartsites of primary set and y-site of extension set.The root cause could not be definitively determined.

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 further patient or event information available.

• Brand Name: MAXZERO NEEDLELESS CONNECTOR
• Type of Device: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9163001
• MDR Text Key: 161843015
• Report Number: 9616066-2019-02803
• 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: 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: (2) 2420-0007, (2) CUROS CAPS, THERAPY DATE UNK