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

Model Number DP1800SC

Device Problems Leak/Splash (1354); Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

During monthly sq remodulin consult (patient is at maintenance.Dose 71.8 ng/kg/min, 0.044 ml/hr pump rate.Using 2.6 ml remodulin 10 mg/ml every 48 hours), patient reported that the spikes we provide make her vials leak.She said she is able to work around this, but that the latches that attach to the vial are not strong/secure and allow for leaking.Unknown if pt still has defect spike on hand if needed for return.No additional information available at this time.Reported to (b)(6) by pt/caregiver.

• Brand Name: MINI SPIKE DIS PIN
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): B. BRAUN MEDICAL AG
• MDR Report Key: 15625480
• MDR Text Key: 302024469
• Report Number: MW5112680
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• 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: 10/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DP1800SC
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Female