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

Model Number 2426-0007

Device Problems Defective Component (2292); Incomplete or Inadequate Connection (4037); Air/Gas in Device (4062)

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

Event Date 03/30/2023

Event Type  malfunction  

Event Description

Two different patients with defective connection tubing to iv's causing significant amounts of air to continuously enter the line.Connection tubing replaced on both patients without harm occurring.Manufacturer response for set, administration, intravascular, alaris, smartsite (per site reporter).Sent complaint form to bd.

• Brand Name: ALARIS, SMARTSITE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 16723697
• MDR Text Key: 313142131
• Report Number: 16723697
• Device Sequence Number: 1
• Product Code: FPA
• 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: 04/05/2023

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: Other
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Device Lot Number: NOT KNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/05/2023
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/12/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/12/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27375 DA
• Patient Sex: Male