MAUDE Adverse Event Report: UNKNOWN MIX 2 TRANSFER VIAL; SET, I.V. FLUID TRANSFER

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Date 05/20/2022

Event Type  malfunction  

Event Description

Transfer device failed to pull diluent into the powder vial for reconstitution.Von willebrand disease.

• Brand Name: MIX 2 TRANSFER VIAL
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): UNKNOWN; unknown; unknown
• MDR Report Key: 14495191
• MDR Text Key: 292991140
• Report Number: MW5109904
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 05/20/2022

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
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/24/2022
• Patient Sequence Number: 1
• Patient Age: 24 YR
• Patient Sex: Female
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic