MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG NON-VENTED DISPENSING PIN WITH LUER LOK SAFSITE VALVE; SET, I.V. FLUID TRANSFER

Lot Number 0061727234

Device Problem Incomplete or Missing Packaging (2312)

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

Event Date 07/06/2020

Event Type  malfunction  

Event Description

A number of non-vented dispensing pin with luer lock safsite valves were found to have been packaged without the blue pin stopper.It seems to have only affected one lot number.Included with this report are pictures of what the dispensing pin looks like normally (with the blue pin stopper) and ones that do not have the blue pin stopper.

• Brand Name: NON-VENTED DISPENSING PIN WITH LUER LOK SAFSITE VALVE
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG
• MDR Report Key: 10250640
• MDR Text Key: 198378148
• Report Number: MW5095450
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/07/2020

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: No Information
• Device Lot Number: 0061727234
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/08/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1