MAUDE Adverse Event Report: THE METRIX COMPANY PORT BAG CORAM EVA 2 CONTAINER, I.V.

Model Number 66050

Device Problem Connection Problem (2900)

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

Event Type  malfunction  

Event Description

Patient's nurse reported difficulty connecting fluid transfer set to port bag. Wanted to check other options. Solicited call. No additional information. Indication: chronic inflammatory, demyelinating polyneuritis. No missed dose was reported. No adverse event was reported. Unknown reason for difficulty. Unknown if products on hand for return to the manufacturer. Reported to (b)(6) by health professional.

• Brand Name: PORT BAG CORAM EVA 2
• Type of Device: CONTAINER, I.V.
• Manufacturer (Section D): THE METRIX COMPANY
• MDR Report Key: 11528475
• MDR Text Key: 241432260
• Report Number: MW5100110
• Device Sequence Number: 2
• Product Code: KPE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/12/2021
• 2 Devices were Involved in the Event: 1 2

0 Patients were Involved in the Event:

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 66050
• Device Catalogue Number: 66050
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage