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

Model Number DP1800SC

Device Problems Fluid/Blood Leak (1250); Improper or Incorrect Procedure or Method (2017)

Patient Problems Dyspnea (1816); Pain (1994); Hypervolemia (2664)

Event Type  Injury  

Event Description

Patient reports they recently had a root canal and did not titrate while recovering.Patient reports they have been having some fluid retention which has increased their shortness of breath.Patient also reports having feet and lower leg pain.Patient is following up with their doctor and they are aware.Patient also reports their current spike on the remodulin vial seems to be leaking and has caused them to lose a bit of medication.Author advised pharmacy will dispense extra spikes with this refill.Spike lot number unknown.Unknown if product is available for return.No adverse event reported due to spike issue.No further information, details or dates available.Iv remodulin pt.Pt is actively taking remodulin.Reported to (b)(6) by pt/caregiver.

• Brand Name: MINI SPIKE DIS PEN
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 16940669
• MDR Text Key: 315389750
• Report Number: MW5117564
• 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: 05/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: DP1800SC
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/15/2023
• Patient Sequence Number: 1
• Treatment: REMODULIN
• Patient Sex: Female