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

Model Number MZ1000 CHINA

Device Problem Device Damaged Prior to Use (2284)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/23/2019

Event Type  malfunction  

Manufacturer Narrative

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.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.

Event Description

The reported feedback suggests that the inner rubber of the connector was sunken and the surface was inclined.Report suggests not in use on a patient.

Event Description

The reported feedback suggests that the inner rubber of the connector was sunken and the surface was inclined.

Manufacturer Narrative

A visual inspection initially confirmed the customer's report as the piston was found in the recessed position.However, functional testing was performed by connecting and disconnecting a 50ml bd plastipak syringe from retained bd stock; in each instance the blue piston returned to its closed position following disconnection.In addition the returned mz1000 product was subjected to functional testing using various other male luers from bd stock; the recessed piston could not be replicated upon disconnection.Previous investigations have identified that recessed pistons can occur as a result of a core pin mismatch which results in a slight step being formed within the component.A review of the production records did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.

• 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: 9310501
• MDR Text Key: 190507414
• Report Number: 9616066-2019-03237
• Device Sequence Number: 1
• Product Code: FPA
• 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: 09/24/2019

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 Model Number: MZ1000 CHINA
• Device Catalogue Number: MZ1000 CHINA
• Device Lot Number: 18046980
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/12/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1