MAUDE Adverse Event Report: THE METRIX COMPANY SECURE; 250 ML EVA 2 PORT BAG

Model Number	66405
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354); Mechanical Problem (1384)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
The metrix company received a report from a user facility regrading the occurrence of leak on a 250 ml eva bag.The leak was noted by an end user.Metrix's customer supplied the following details: "pt on milrinone cont.Pt daughter visited to change the bag and reported that pump was alarming and bag was empty.The pouch was totally wet.Pt daughter thinks bag was empty for approx 3 hrs.The bag was 250ml eva bag 66045/a5338-fo lot a4999 exp 9/21.The daughter threw the bag out when she changed it.The pump works fine.Pt is fine." as the end user discarded the bag, it was not available for evaluation.A review of the device history record for the lot in question shows no manufacturing nor quality issues.No similar complaints have been received for the 250 ml eva bag.At this time metrix is unable to confirm whether the bag itself was leaking or if the leak was related to the administration set or user error.

• Brand Name: SECURE
• Common Device Name: 250 ML EVA 2 PORT BAG
• Manufacturer (Section D): THE METRIX COMPANY; 4400 chavenelle road; dubuque IA 52002
• MDR Report Key: 10501983
• Report Number: 1937141-2020-00001
• Device Sequence Number: 16939612
• Product Code: KPE
• UDI-Device Identifier: 00812496011756
• UDI-Public: 00812496011756
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K030888
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/30/2021
• Device Model Number: 66405
• Device Catalogue Number: 66045
• Device Lot Number: 66045-A4999
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2020
• Initial Report FDA Received Date: 09/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1