MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. MINI SPIKE DISPENSING PIN; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Defective Device (2588)

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

Event Type  malfunction  

Event Description

Spontaneous.Patient reported defective medication.Per patient when she attempted to spike 2 of her treprostinil 5mg/ml (dose 117 ng/kg/min) vials, the mini spike pushed the grey stopper down and into her medication vial.Pt reports that she has the vials and the spikes available to return.Expiration dates not provided at this time as pt was at work.Lot number for mini spike unavailable at this time as pt was at work.Pt reports still having 7 days on hand of medication.Pt reports no interruption in treatment due to this product complaint.No adverse events reported.No additional details/dates available at time of submission.Reported to (b)(6) by: patient/caregiver.Reference report #mw5117898.

• Brand Name: MINI SPIKE DISPENSING PIN
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 17010245
• MDR Text Key: 316150668
• Report Number: MW5117899
• Device Sequence Number: 1
• Product Code: FPA
• 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: 05/23/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/25/2023
• Patient Sequence Number: 1
• Patient Sex: Female