MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. BRAUN 35; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 354220

Device Problems Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)

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

Event Date 02/09/2021

Event Type  Injury  

Event Description

Iv tubing was investigated and iv extension tubing (braun 35 inch extension set) found to be defective.The tubing disconnected at port junction (not a connection site disconnect, the tubing essentially cut in half).Iv fluid was leaking into patient's bed.Fda safety report id# (b)(4).

• Brand Name: BRAUN 35
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC. ; bethlehem PA 18018 3524
• MDR Report Key: 11552954
• MDR Text Key: 242051955
• Report Number: MW5100173
• Device Sequence Number: 1
• Product Code: FPA
• 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: 03/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: 354220
• Device Catalogue Number: 04046964182341
• Device Lot Number: 0061759548
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 21 YR