MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. MINI SPIKE DISP PIN; DISPENSER, LIQUID MEDICATION

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

Event Type  malfunction  

Event Description

Patient reports that she has had an issue with a few spikes.Does not have lot number.States drug leaked through vent part of the spike one time, and another instance she had a spike that she states she wasted a lot of drug because she was not able to get drug out of the vial with the spike she had.Product lot number and expiration date are unknown.Unknown if patient missed dose or experienced adverse event.Unknown if patient has product on hand.Date of product complaint is unknown.No other information known.Reported to (b)(6) by: patient/caregiver.Reference report: #mw5149720.

• Brand Name: MINI SPIKE DISP PIN
• Type of Device: DISPENSER, LIQUID MEDICATION
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 18435232
• MDR Text Key: 331985147
• Report Number: MW5149721
• Device Sequence Number: 1
• Product Code: KYX
• 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: 12/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• 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
• Treatment: REMODULIN MDV.; STERILE DILUENT FOR REMODULIN.
• Patient Sex: Female