MAUDE Adverse Event Report: THE METRIX COMPANY SECURE; 100 ML 2 PORT PVC BAG

Model Number	58719
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that particulate was found in 13 units of the secure 100 ml 2 port pvc bags, lot 58719-31578.The particulate was noted by the pharmacy upon inspection after the bags were filled.There is no report of patient injury or death.The particulates are in the process of being analyzed by a third party laboratory.Initial visual results indicate scrape marks on the interior of the injection site which may be consistent with needle contact with the injection site wall during the filling of the bag.Should additional relevant information become available, a follow-up report will be filed.
Additional Manufacturer Narrative
The injection site is the only port available for filling the bags with fluid.Each of the 13 units returned for evaluation had been filled by the pharmacy.The units were sent to an external laboratory for evalution.The injection site was visually examined and all 13 units were confirmed to have scrape marks present on the injection site wall.As the particulate within each of the bags was visually similar, three bags were randomly selected, the particulate from each bag was isolated and composition testing was conducted.On all 3 bags the particulate was identified as having the same composition as the injection site wall.The source of the particulate is assessed to be needle contact with the injection site wall during the filling process at the pharmacy.H6: investigation findings and investigation conclusions were corrected based on the device evaluation results.

• Brand Name: SECURE
• Common Device Name: 100 ML 2 PORT PVC BAG
• Manufacturer (Section D): THE METRIX COMPANY; 4400 chavenelle road; dubuque IA 52002
• MDR Report Key: 11848208
• Report Number: 1937141-2021-00006
• Device Sequence Number: 4015194
• Product Code: KPE
• UDI-Device Identifier: 20812496011859
• UDI-Public: 20812496011859
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K843523
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2021

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: Health Professional
• Device Model Number: 58719
• Device Catalogue Number: 58719
• Device Lot Number: 58719-31578
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2021
• Supplement Date Received by Manufacturer: 04/22/2021
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 06/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1