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	10/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pictures provided by the patient show both chambers of the bag with intact fluid and no apparent leak location.Should additional relevant information become available, a supplemental report will be filed.
Event or Problem Description
Customer reported one unit of a compounded parenteral nutrition (pn) bag that was found to be leaking at a patient's home prior to use.The patient reported "the bag i opened last night and noticed some pn fluid in the over pouch when i cut it open- maybe around 20 mls? it poured out onto the bench after i cut the over pouch open.I can't seem to find an obvious leak on the pn bag but the mixing port is saturated along with the outside of the pn bag.Images are of the next morning so unable to provide pictures of the fluid spill as this was cleaned up." there was no report of patient injury or medical intervention as a result of this event.The patient confirmed there was skin contact with the spilled pn solution.Customer confirmed they immediately washed their hands with soap and water.The customer stated they did not observe any damage to the product overpouch, delivery box or other items within the box.The customer stated "was only a little fluid that had leaked onto the outside of another bag, but this was a very small amount (mainly droplets) and i wiped it clean with a large alcohol wipe.".

• 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
• Manufacturer (Section G): METRIX DOMINICANA; parque industrial itabo; building 5; san cristobal, ; DR
• Manufacturer Contact: jennifer clasen ; 4400 chavenelle road; dubuque, IA 52002 ; 5635568800
• MDR Report Key: 15698405
• Report Number: 1937141-2022-00011
• Device Sequence Number: 17730760
• 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: Foreign,Consumer,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/31/2022

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 Model Number: H938905
• Device Catalogue Number: H938905
• Device Lot Number: 63630-A7060
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2022
• Initial Report FDA Received Date: 10/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown