MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. IV PUMP SET CARESITE 15DROPS/ML PRIMARY TUBING; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 490100

Device Problem Fitting Problem (2183)

Patient Problem Insufficient Information (4580)

Event Date 02/16/2023

Event Type  malfunction  

Event Description

Bbraun primary tubing were too short to fit into the infusion pump.Lot #0061850538, product #490100.

• Brand Name: IV PUMP SET CARESITE 15DROPS/ML PRIMARY TUBING
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 16436564
• MDR Text Key: 310281105
• Report Number: MW5115143
• 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: 02/17/2023

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: Health Professional
• Device Catalogue Number: 490100
• Device Lot Number: 0061850538
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/23/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INFUSION PUMP