MAUDE Adverse Event Report: B. BRAUN MEDICAL, INC. ONGUARD SYRINGE ADAPTOR LOCK; SET, I.V. FLUID TRANSFER

Model Number 412126

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/08/2019

Event Type  malfunction  

Event Description

This product is supposed to lock on; on initial inspection it did appear to lock on to our alaris tubing.It was discovered that the twisting luer lock cover can become loose during infusion and the device disconnects causing hazardous drug to spill and leaving the central line open.This product does not effectively lock onto alaris pump tubing during infusion.

• Brand Name: ONGUARD SYRINGE ADAPTOR LOCK
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.; 901 marcon blvd.; allentown PA 18109
• MDR Report Key: 8398552
• MDR Text Key: 138084894
• Report Number: 8398552
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 412126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/14/2019
• Date Report to Manufacturer: 03/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 10585 DA