MAUDE Adverse Event Report: BD / CAREFUSION 303, INC. BD ALARIS PUMP INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Lot Number 2420-0500

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Iv tubing leaking at upper portion of diaphragm.Fda safety report id# (b)(4).

• Brand Name: BD ALARIS PUMP INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BD / CAREFUSION 303, INC.
• MDR Report Key: 12925297
• MDR Text Key: 281835610
• Report Number: MW5105766
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 2420-0500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 1 YR
• Patient Sex: Male