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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Spontaneous call from the patient stating that she losing medication while using the remodulin spikes.Instructed her to make sure that the "spike" was attached properly to the remodulin vial.Even then the patient requested that we sent the mini spikes used for veletri vials.Patient has been using the veletri mini spikes, 37279 mini spike disp pin.No further information or dates are known.Reported to (b)(6) by: patient/caregiver.

• Brand Name: MINI SPIKE IV DISP PIN
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): B. BRAUN MELSUNGEN AG
• MDR Report Key: 12413214
• MDR Text Key: 270255881
• Report Number: MW5103666
• 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: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2021
• Patient Sequence Number: 1