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

Device Problems Use of Device Problem (1670); Improper Flow or Infusion (2954)

Patient Problems Headache (1880); Nausea (1970); Vomiting (2144)

Event Date 03/01/2021

Event Type  malfunction  

Event Description

Patient reports a couple days of side effects (headache, nausea/vomiting, not feeling well) after last increase of veletri on (b)(6) 2021 patient reports she has had multiple instances where it has been difficult to withdraw diluent using the budp1800sc spike.Patient did not have lot information.Patient will continue to use spike but make sure to have extra on hand.Patient will save lot info if she continues to have issues.No other information available.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 MEDICAL INC.
• MDR Report Key: 11684967
• MDR Text Key: 246262130
• Report Number: MW5100832
• 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: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 50 YR