MAUDE Adverse Event Report: B. BRAUN MELSUNGEN AG MINI SPIKE DISP PIN ; SET, I.V, FLUID TRANSFER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Purulent Discharge (1812)

Event Date 07/27/2019

Event Type  Injury  

Event Description

Pt's wife reports infusion site came out with some pus, no fowl smell, not red, no fever or other signs of infection.Pt started new site with fresh tubing.No other info known.Md rems id (b)(6).Reported to (b)(6) by pt/caregiver.

• Brand Name: MINI SPIKE DISP PIN
• Type of Device: SET, I.V, FLUID TRANSFER
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG
• MDR Report Key: 8860916
• MDR Text Key: 153402171
• Report Number: MW5088729
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): Y
• 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: 07/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 42 YR