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

Model Number MZ1000

Device Problem Backflow (1064)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/05/2019

Event Type  malfunction  

Manufacturer Narrative

Mz1000/no 510k this is an international code- the model#/catalog# identified in section is a carefusion product which is same or similar to a device that is approved for sale domestically.The domestic similar list number is (b)(4).The 510k number provided in section is for the domestic similar product.(b)(4).No product returned.Because no product was returned or expected to be returned, no failure investigation could be performed.The root cause of the customer's experience was not identified.

Event Description

The reported feedback suggests that there was back flow.The customer stated that the maxzero when flushed with saline, blood returns and fills the product with blood.The customer did not report any leakage.Device will not be available for return.

• Brand Name: MAXZERO NEEDLELESS CONNECTOR
• Type of Device: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: sylvia ventura ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 9528326
• MDR Text Key: 191448910
• Report Number: 9616066-2019-03759
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K132413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MZ1000
• Device Catalogue Number: MZ1000
• Device Lot Number: 19095540
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1