MAUDE Adverse Event Report: THE METRIX COMPANY SECURE; 50ML 2 PORT EVA BAG

Model Number 66043

Device Problem Contamination (1120)

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

Event Type  malfunction  

Event Description

It was reported that particulate was found in 2 to possibly 9 units of the secure 50 ml 2 port eva bags, lot 66043-a6591.Later it was reported an additional 9 units were identified with particulate.The particulate was noted by the same pharmacy upon inspection after the bags were filled.There is no report of patient injury or death.The particulates are in the process of being analyzed by a third party laboratory.Should additional relevant information become available, a follow-up report will be filed.

Manufacturer Narrative

Should additional relevant information become available, a follow-up report will be filed.

• Brand Name: SECURE
• Type of Device: 50ML 2 PORT EVA BAG
• Manufacturer (Section D): THE METRIX COMPANY; 4400 chavenelle road; dubuque IA 52002
• MDR Report Key: 11814968
• MDR Text Key: 264157473
• Report Number: 1937141-2021-00005
• Device Sequence Number: 1
• Product Code: KPE
• UDI-Device Identifier: 50812496011577
• UDI-Public: 50812496011577
• Combination Product (y/n): N
• PMA/PMN Number: K030888
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/10/2023
• Device Model Number: 66043
• Device Catalogue Number: 66043
• Device Lot Number: 66043-A6591
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1