MAUDE Adverse Event Report: THE METRIX COMPANY SECURE; 3000 ML EMPTY EVA DUAL CHAMBER CONTAINER WITH 5 PORT MANIFOLD FILL SET

Model Number	66631
Medical Device Problem Codes	Contamination /Decontamination Problem (2895); Device Contamination with Chemical or Other Material (2944); Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual inspection was done on the returned unit and a discolored area was confirmed within the upper chamber of the filled bag.The unit was sent to an external lab for analysis and the results are pending.A batch review was conducted and there were no deviations found related to this reported condition during the quality control inspection of this lot.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a stain was embedded inside the lipid chamber of a secure eva dual chamber 3000 ml bag with 5 port manifold fill set.The stain was noted in the filled bag by the pharmacy during the packing process.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
The external lab evaluated the returned unit and determined that the discolored area observed by the customer was located on the exterior of the bag.No discoloration or stain was found on the interior of the bag.The external lab further determined the discolored area consisted of a dark particle deposited on the surface of the bag.The particle was analyzed and found to be a charred organic substance.The particle was accompanied by scrape marks on the exterior of the bag which suggests the particle was deposited during an abrasion event.A source for the charred organic material could not be identified within the manufacturing process.As the unit was filled by the pharmacy, it is possible the abrasion event occurred during the use of the device.As the stain was confirmed to be on the exterior of the unit, there is no assessed risk to the health.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: SECURE
• Common Device Name: 3000 ML EMPTY EVA DUAL CHAMBER CONTAINER WITH 5 PORT MANIFOLD FILL SET
• Manufacturer (Section D): THE METRIX COMPANY; 4400 chavenelle road; dubuque IA 52002
• MDR Report Key: 12017997
• Report Number: 1937141-2021-00012
• Device Sequence Number: 14588086
• Product Code: KPE
• UDI-Device Identifier: 20812496011514
• UDI-Public: 20812496011514
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K960581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2021

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: Other
• Device Model Number: 66631
• Device Catalogue Number: 66631
• Device Lot Number: 66631-A6718
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 06/17/2021
• Supplement Report FDA Received Date: 07/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1