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

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)

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

Event Date 05/26/2022

Event Type  malfunction  

Event Description

The connection on the port of the douglas medical ecoflex bag was loose causing the spike to come out and the bag contents to leak on the floor.Fda safety report id# (b)(4).

• Brand Name: DOUGLAS MEDICAL ECOFLX BAG EMPTY MIXING CONTAINERS
• Type of Device: CONTAINER, I.V.
• Manufacturer (Section D): DOUGLAS MEDICAL PRODUCTS, INC.; mundelein IL 60060
• MDR Report Key: 14933966
• MDR Text Key: 295477183
• Report Number: MW5110669
• Device Sequence Number: 1
• Product Code: KPE
• 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: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1