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

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Patient was only drawing 1.8ml since she never received a new dose guide.Md office advised she should be drawing 2.8ml for each cartridge.Patient was counseled.Patient also stated her vial leaked some (date unknown) and thought the spike may have been the cause.Indication: pulmonary arterial hypertension (pah).No additional adverse events or side effects were mentioned by a patient due to product issue.Unknown if patient still has product on hand.Lot and expiration date are unknown.No side affects or adverse events mentioned by patient due to product use error.No further information was provided by reporter during contact.Reported to (b)(6) by: patient/caregiver.

• Brand Name: MINI SPIKE DISP PIN
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): B. BRAUN MEDICAL, INC.
• MDR Report Key: 8857365
• MDR Text Key: 153839994
• Report Number: MW5088711
• 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: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2019
• 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
• Patient Sequence Number: 1