MAUDE Adverse Event Report: B. BRAUN IV ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Event Description

Customer reported that the b.Braun safe day iv administration set had a hole in the iv-tubing and leaked medication; blood from the extracorporeal system.Ni.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: IV ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN
• MDR Report Key: 17535795
• MDR Text Key: 321094125
• Report Number: MW5142689
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1