MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. IV ADMINISTRATION SET; STOPCOCK, I.V. SET

Model Number 490225

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 06/23/2023

Event Type  malfunction  

Event Description

Tubing found broken on stopcock part; no trauma to tubing.

• Brand Name: IV ADMINISTRATION SET
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 17240044
• MDR Text Key: 318289790
• Report Number: MW5119029
• Device Sequence Number: 1
• Product Code: LHI
• 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: 06/23/2023

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 Model Number: 490225
• Device Lot Number: 00VL868179
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/29/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic