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

Model Number MZ1000-07

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: 2.5ml monoject syringe, lot 19h0904, exp 2021-07-31, 0.9% nacl.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.Patient's demographics requested, but was not provided.

Event Description

It was reported that the iv tubing set leaked at the connection.There was no patient impact.

Event Description

It was reported that the iv tubing set leaked at the connection.It was further confirmed that there was no patient harm as a result of this event.

Manufacturer Narrative

The customer¿s report of a leak at the connection where syringe attaches to another component was confirmed.Visual inspection of the set noted no damage or any anomalies.Inspection of the recently mated components observed no obvious damages or issues.Functional testing confirmed leaking at the engagement of the syringe and maxzero.Pressure testing resulted in no leaking.The maxzero measured to be within iso specification(s).The root cause was due to an issue with the non-bd syringe.No issues were observed with the bd samples.

• 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: 9525853
• MDR Text Key: 191112415
• Report Number: 9616066-2019-03745
• 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: 12/06/2019

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: 08/28/2022
• Device Model Number: MZ1000-07
• Device Catalogue Number: MZ1000-07
• Device Lot Number: 19086301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 10014914,NON-BD EXT SET, THERAPY DATE (B)(6) 2019