MAUDE Adverse Event Report: DOUGLAS MEDICAL PRODUCTS, INC. ECOFLX 150ML EMPTY MIXING CONTAINER; CONTAINER, I.V.

Model Number DMP0150

Device Problems Fluid/Blood Leak (1250); Product Quality Problem (1506); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/12/2022

Event Type  malfunction  

Event Description

Pt receiving fentanyl infusion 1000 mcg/100ml, during discontinuation of therapy and line tracing, tubing disconnected from iv bag resulting in remaining fentanyl fluid spilling on pt, nurse and floor.The iv tubing connection site in the iv bag was loose and resulted in the iv spike dislodgement with normal iv line manipulation.Escalation was made to the compounding pharmacy who responded that they have received multiple complaints of the same nature after switching to douglas medical ecoflx empty iv infusion bags.

• Brand Name: ECOFLX 150ML EMPTY MIXING CONTAINER
• Type of Device: CONTAINER, I.V.
• Manufacturer (Section D): DOUGLAS MEDICAL PRODUCTS, INC.
• MDR Report Key: 14756639
• MDR Text Key: 294601809
• Report Number: MW5110405
• Device Sequence Number: 1
• Product Code: KPE
• 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: 06/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DMP0150
• Device Lot Number: B21-5526
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 16 YR
• Patient Sex: Female
• Patient Weight: 41 KG