MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. NON-VENTED DISPENSING PIN WITH LEVER LOK SAFSITE VALVE ; SET, INTRAVASCULAR, ADMINISTRATION

Lot Number 0061686384

Device Problem Contamination (1120)

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

Event Date 10/18/2019

Event Type  malfunction  

Event Description

Non-vented dispensing pin with lever lok has some black substance coating the spike port and cap.

• Brand Name: NON-VENTED DISPENSING PIN WITH LEVER LOK SAFSITE VALVE
• Type of Device: SET, INTRAVASCULAR, ADMINISTRATION
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 9260807
• MDR Text Key: 164843376
• Report Number: MW5090804
• Device Sequence Number: 1
• Product Code: FPA
• 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: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 0061686384
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1