MAUDE Adverse Event Report: DOUGLAS MEDICAL PRODUCTS, INC. ECOFLX EMPTY MIXING CONTAINER; CONTAINER, I.V.

Model Number	DMP0150
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Douglas medical product ecoflx empty mixing containers have had multiple malfunctions of leaking partially or entirely, both in patient rooms and in medication rooms when spiked.At times it has occurred while spiking and other times it has occurred after being spiked, spontaneously leaking.

• Brand Name: ECOFLX EMPTY MIXING CONTAINER
• Common Device Name: CONTAINER, I.V.
• Manufacturer (Section D): DOUGLAS MEDICAL PRODUCTS, INC.; 361 banbury rd; mundelein IL 60060
• MDR Report Key: 15026315
• Report Number: 15026315
• Device Sequence Number: 4534603
• Product Code: KPE
• UDI-Device Identifier: 00816415020430
• UDI-Public: (01)00816415020430
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/12/2022
• Report Date (Section F): 07/12/2022

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
• Operator of Device: Health Professional
• Device Model Number: DMP0150
• Device Catalogue Number: DMP0150
• Device Lot Number: B21-5536
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/15/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/15/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 20 KG
• Patient Ethnicity: Hispanic
• Patient Race: Black Or African American
• Date Report Sent to FDA: 07/12/2022