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

Model Number MZ1000-07

Device Problem Failure to Disconnect (2541)

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.Although requested, patient demographics was not provided.

Event Description

It was reported that it is very difficult to unscrew flush from the clave.The user ends up unscrewing the clave from the central line and exposing the line.This has happened several times.Although requested, additional information was not provided.

Manufacturer Narrative

Additional info: d.11.

Event Description

It was reported that it is very difficult to unscrew flush from the clave.The user ends up unscrewing the clave from the central line and exposing the line.This has happened several times.Although requested, additional information was not provided.

Event Description

It was reported that it is very difficult to unscrew flush from the clave.The user ends up unscrewing the clave from the central line and exposing the line.This has happened several times.Although requested, additional information was not provided.

• 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: 9913478
• MDR Text Key: 194329451
• Report Number: 9616066-2020-01198
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2020

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 Expiration Date: 08/22/2022
• Device Model Number: MZ1000-07
• Device Catalogue Number: MZ1000-07
• Device Lot Number: 19087577
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/01/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/09/2020; 05/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SYRINGE FLUSH, CENTRAL LINE, TD UNK