MAUDE Adverse Event Report: ARGON MEDICAL DEVICES MAXIMAL BARRIER INSERTION TRAY; MICROBORE EXTENSION SET

Model Number	384835
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expected to return for evaluation.
Event or Problem Description
Microbore extension set was leaking where the tube and connector meet.
Additional Manufacturer Narrative
The sample was returned for evaluation and the investigation is in progress.A final report will be submitted once the investigation has been completed.
Event or Problem Description
Microbore extension set was leaking where the tube and connector meet.
Additional Manufacturer Narrative
One extension set was returned for review.No lot number was provided.Functional testing did not find any leakage.The failure could not be replicated and the complaint could not be confirmed.
Event or Problem Description
Microbore extension set was leaking where the tube and connector meet.

• Brand Name: MAXIMAL BARRIER INSERTION TRAY
• Common Device Name: MICROBORE EXTENSION SET
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• MDR Report Key: 11860902
• Report Number: 0001625425-2021-00946
• Device Sequence Number: 19720560
• Product Code: OWL
• UDI-Device Identifier: 00886333210091
• UDI-Public: 00886333210091
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 384835
• Device Catalogue Number: 384835
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 06/15/2021; 06/25/2021
• Initial Report FDA Received Date: 05/20/2021
• Supplement Report FDA Received Date: 06/15/2021; 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention