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

Model Number BUDP1000

Device Problems Insufficient Flow or Under Infusion (2182); Defective Device (2588)

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

Event Type  malfunction  

Event Description

Spoke with pt regarding xembify.She was able to get 45/50 ml out of the vial.Pt said it was dripping out and took her hours to get the medication out of the vial.When she used mini spike for a different vial prior, it was dripping too slowly for her to get medication out.Patient believes it may be due to the spikes.They might be defective/not big enough.No further information provided.Patient did not miss a dose or experience an adverse event as a result of defective product.Unknown if patient still has defective mini spike on hand to return to pharmacy or if patient has disposed of supply.Indications: nonfamilial hypogammaglobulinemia; chronic sinusitis, unspecified.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 MELSUNGEN AG
• MDR Report Key: 16445393
• MDR Text Key: 310374708
• Report Number: MW5115217
• Device Sequence Number: 1
• Product Code: LHI
• 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: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 02/09/2024
• Device Model Number: BUDP1000
• Device Lot Number: P100014491
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Sex: Female