MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. INFUSAMAT 15 GTT PRIMARY SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 490100

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

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

Event Date 11/18/2022

Event Type  malfunction  

Event Description

Tubing chamber leaking iv (intravenous) fluid - appears to be a hole in the tubing.Fda safety report id #(b)(4).

• Brand Name: INFUSAMAT 15 GTT PRIMARY SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 15864948
• MDR Text Key: 304424738
• Report Number: MW5113482
• 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: 11/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 490100
• Device Catalogue Number: 490100
• Device Lot Number: 0061837894
• 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
• Treatment: IV INFUSION