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

Device Problems Fluid/Blood Leak (1250); Insufficient Flow or Under Infusion (2182); Patient Device Interaction Problem (4001)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  malfunction  

Event Description

Patient reported leakage from mini spikes when withdrawing hizentra medication from vials when refilling her hizentra.Leakage caused an adverse event since pt did not receive all of infusion.No defective lat number was given or expiration.Patient did not save her defective product.Patient prefers 18gx l" needles to withdraw instead.No further information provided.Reported to (b)(6) by pt/caregiver.

• Brand Name: MINI SPIKE IV DISP PIN
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): B. BRAUN MEDICAL AG
• MDR Report Key: 14830111
• MDR Text Key: 294940128
• Report Number: MW5110521
• 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: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Female