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

Device Problems Fluid/Blood Leak (1250); Connection Problem (2900)

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

Event Type  malfunction  

Event Description

Indication: antibody deficiency with near-normal immunoglobulins or with hyperimmunoglobulinemia.Patient's caretaker reported that the connectors for the vials leak.No missed dose or adverse effect reported.Unknown if pins are available for return.Unknown if md aware.No further information provided.Unknown if occurred while in use with the patient.Reported to (b)(6) by: patient/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: 16051443
• MDR Text Key: 306326012
• Report Number: MW5114013
• 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: 12/13/2022

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: 12/23/2022
• Patient Sequence Number: 1
• Patient Sex: Female