MAUDE Adverse Event Report: CAREFUSION 303, INC. MAXZERO; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MZ5303

Device Problems Leak/Splash (1354); Fitting Problem (2183); Incomplete or Inadequate Connection (4037)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2023

Event Type  malfunction  

Event Description

New iv connector mz5303 with the white caps do not fully screw into the hub of the intracath.We have had at least 2 instances where the connection failed and the patient did not receive contrast because it leaked out.This appears to be manufactured differently than previous shipments of the same product.No harm occurred to the patient.

• Brand Name: MAXZERO
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 16701436
• MDR Text Key: 312887798
• Report Number: 16701436
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403230561
• UDI-Public: (01)10885403230561
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MZ5303
• Device Catalogue Number: MZ5303
• Device Lot Number: (10)22119226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/17/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/07/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25915 DA
• Patient Sex: Male