MAUDE Adverse Event Report: THE METRIX COMPANY SECURE; 1500 ML EMPTY EVA DUAL CHAMBER CONTAINER WITH 5 PORT MANIFOLD FILL SET

Model Number	66616
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation.A visual inspection was done and a clear/white fiber-like particulate was identified within the filled bag.The unit was sent to an external lab for analysis of the particulate and the results show the closest match to polyethylene.A batch review was conducted and there were no deviations found related to this reported condition during the quality control inspection of this lot.The cause of the condition is being investigated.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a floater was found inside a secure eva dual chamber 1500 ml bag with 5 port manifold fill set.It was further reported that the fluid was filtered with a 0.2 micron filter, the integrity test passed and no needle punctures were made to the bag.The floater was noted by the pharmacy during the visual inspection of the filled bag at the packaging bench.There was no patient involvement.No additional information is available.

• Brand Name: SECURE
• Common Device Name: 1500 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: 11925131
• Report Number: 1937141-2021-00009
• Device Sequence Number: 3673839
• Product Code: KPE
• UDI-Device Identifier: 20812496011477
• UDI-Public: 20812496011477
• 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): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/02/2021

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: 66616
• Device Catalogue Number: 66616
• Device Lot Number: 66616-A6877
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2021
• Initial Report FDA Received Date: 06/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1