MAUDE Adverse Event Report: THE METRIX COMPANY EXACTAMIX; 3000 ML EMPTY EVA DUAL CHAMBER BAG

Model Number	H938905
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be filed.
Event or Problem Description
It was reported that a single unit of an exactamix 3000 ml dual chamber eva bag was found to be leaking during administration at the patient's home.It was reported that the outside of the bladder bag was wet with a white liquid and upon closer inspection a tiny hole was noted underneath the pn nutrient label.The leak was identified after 170 ml of the solution had been administered.Administration was then ceased.It was reported that the patient has been monitored by mom and no adverse effect was noticed.It was also reported that there was no skin contact with the spilled pn solution.The actual sample was discarded by the customer and no photographs are available.It was reported that the silver overpouch and label were not damaged.The customer confirmed they used their usual method of opening the bag overpouch, carefully using scissors.No additional information is available.

• Brand Name: EXACTAMIX
• Common Device Name: 3000 ML EMPTY EVA DUAL CHAMBER BAG
• Manufacturer (Section D): THE METRIX COMPANY; 4400 chavenelle road; dubuque IA 52002
• MDR Report Key: 12174149
• Report Number: 1937141-2021-00014
• Device Sequence Number: 20001799
• Product Code: KPE
• UDI-Device Identifier: 00085412477473
• UDI-Public: 00085412477473
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K960581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2021

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: 12/17/2025
• Device Model Number: H938905
• Device Catalogue Number: H938905
• Device Lot Number: 63630-A5975
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 07/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1