MAUDE Adverse Event Report: MEDIMOP MEDICAL PROJECTS LTD. VIAL2BAG DC 20MM; SET, IV FLUID TRANSFER

Model Number 6070112

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 05/06/2018

Event Type  malfunction  

Event Description

Device failure.This device is very dependent on user using correct technique, but we had a report of increased failure rates or certain lot number.We are tracking all failures to see if it is a perceived increase or actual increase.

• Brand Name: VIAL2BAG DC 20MM
• Type of Device: SET, IV FLUID TRANSFER
• Manufacturer (Section D): MEDIMOP MEDICAL PROJECTS LTD.; ra'anana 43665 19; IS 4366519
• MDR Report Key: 7518245
• MDR Text Key: 108610650
• Report Number: MW5077253
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2021
• Device Model Number: 6070112
• Device Lot Number: A001
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1