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	01/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Two instances of the tubing on controlled substance bag fell out causing the contents of the bag to spill.
Event or Problem Description
Two instances of the tubing on controlled substance bag fell out causing the contents of the bag to spill.

• 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: 13584034
• Report Number: 13584034
• Device Sequence Number: 5681286
• Product Code: KPE
• UDI-Device Identifier: 10816415020437
• UDI-Public: (01)10816415020437
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 02/07/2022
• Report Date (Section F): 02/07/2022

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 Lot Number: 30022661
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/23/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/23/2022
• 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
• Date Report Sent to FDA: 02/07/2022