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

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Spontaneous communication from pt reporting she was unable to draw up about 5ml using the mini spike iv dispensing pin when she mixed last mix.Pt is titrating/holding dose 43ng/kg/min and 85ml/24h pump rate.Pt is using 3 - 1.5 mg vials per mix.Pt reports that no matter what she does, she is unable to draw up the entire contents of the vial.Pharmacist reviewed with pt that this is vented spike and should not add air.Pt confirmed did not add air and was just not able to retrieve all of the medication from the vial.Pt reports infusing with no issues.Scheduling q-style adapters and vial adapter mckesson clave (alternative adapters) to pt at this time.Pt understood.No further information, details or dates available product lot number and expiration date were systematically retrieved from the dispensing system.Reported to (b)(6) by pt/caregiver.

• Brand Name: MINI SPIKE IV DISP. PIN
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): B. BRAUN MEDICAL INC.
• MDR Report Key: 18400052
• MDR Text Key: 331514924
• Report Number: MW5149590
• 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: 12/21/2023

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: 12/26/2023
• Patient Sequence Number: 1
• Treatment: VELETRI 5DV
• Patient Sex: Female