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

Model Number MZ1000-07

Device Problems Break (1069); Failure to Disconnect (2541)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2020

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.Patient demographics were not provided.

Event Description

It was reported from the nicu that the 1.2 micron filter tubing was stuck in the needleless max zero connector.There was no patient impact.Customer advocacy received a copy of the customer's medwatch report from the fda which states, "1.2 micron filter tubing stuck inside the needleless connector max zero.".

Event Description

It was reported from the nicu that the 1.2 micron filter tubing became stuck in the needleless max zero connector.There was no patient impact.Customer advocacy received a copy of the customer's medwatch report from the fda which states, "1.2 micron filter tubing stuck inside the needleless connector max zero.".

Manufacturer Narrative

The customer¿s report of tubing stuck inside the needleless connector was confirmed upon visual inspection.It was observed there was an unexpected material lodged within the received maxzero female luer.The unexpected material lodged within the maxzero female luer was presumed to be the male luer tip of the 1.2 micron filter tubing (ext tubing).No issue was observed with the maxzero.No testing was able to be performed.The root cause of the customer's report was not identified.

• 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: 10041366
• MDR Text Key: 200458771
• Report Number: 9616066-2020-01466
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/13/2020

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: 04/15/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/09/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8015,8100, TD (B)(6) 2020; PRI TUBING, TD (B)(6) 2020