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U.S. Department of Health and Human Services

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

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THE METRIX COMPANY PORT BAG CORAM EVA 2 CONTAINER, I.V. Back to Search Results
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.
 
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Brand NamePORT BAG CORAM EVA 2
Type of DeviceCONTAINER, I.V.
Manufacturer (Section D)
THE METRIX COMPANY
MDR Report Key11528475
MDR Text Key241432260
Report NumberMW5100110
Device Sequence Number2
Product Code KPE
Number of Events Reported1
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 Received03/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number66050
Device Catalogue Number66050
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

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