MAUDE Adverse Event Report: EMED TECHNOLOGIES CORPORATION VERSARATE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number FP-0010003

Device Problems Infusion or Flow Problem (2964); Physical Resistance/Sticking (4012)

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

Event Date 08/25/2020

Event Type  No Answer Provided  

Event Description

Pt reported during refill call that sometimes the versarate gets stuck and the infusion stops.

• Brand Name: VERSARATE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): EMED TECHNOLOGIES CORPORATION ; el dorado hills CA 95762
• MDR Report Key: 10459925
• MDR Text Key: 204919765
• Report Number: MW5096306
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• 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: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: FP-0010003
• Device Lot Number: 1911007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 61