MAUDE Adverse Event Report: CAREFUSION MAX ZERO; IV INFUSING TUBING

Device Problem Detachment Of Device Component (1104)

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

Event Date 08/22/2017

Event Type  malfunction  

Event Description

Went to adjust the iv connector and it came off.Hub disconnected from the twisting area.Unable to identify a lot number to the product.All pieces accounted for.

• Brand Name: MAX ZERO
• Type of Device: IV INFUSING TUBING
• Manufacturer (Section D): CAREFUSION
• MDR Report Key: 6830274
• MDR Text Key: 84002171
• Report Number: MW5071823
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1