MAUDE Adverse Event Report: ARGON MEDICAL DEVICES 12CC CONTROL SYRINGE FR/TR/RA W/RESERVOIR

Model Number	193210
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.
Event or Problem Description
Syringe connection to medline manifold was allowing air to be entrapped in the system ¿ hence, potential for air embolus high.Another 12cc argon syringe was opened which had no issues.Medline manifold was used during the time of event.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no similar concerns were found.One opened syringe was returned for review.Visual inspection found no damage to the product.The syringe was filled with water, air bubbles removed, and capped off at the male luer.Forward movement of the plunger resulted in no leakage observed.However, backward movement of the plunger resulted in visible bubbles at the top portion of the silicone stopper.Therefore, this complaint was confirmed.The stopper was removed from the syringe for a closer examination and rough edges or gaps in the silicone were observed on the surface of the stopper.These imperfections in the silicone would allow for air to pass.The most probable cause for the damage to the stopper was most likely due to the molding of the product and the defect was not detected during visual inspection.This component is a purchased item.There have been no other complaints regarding this issue with this lot number.This issue was most likely an isolated event.The area supervisor was made aware of this complaint and provided images of the stopper defect.A training was provided to the operators regarding the reported issue.Argon will continue to monitor for future occurrences.
Event or Problem Description
Syringe connection to medline manifold was allowing air to be entrapped in the system ¿ hence, potential for air embolus high.Another 12cc argon syringe was opened which had no issues.Medline manifold was used during the time of event.

• Brand Name: 12CC CONTROL SYRINGE FR/TR/RA W/RESERVOIR
• Common Device Name: CONTROL SYRINGE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 16761726
• Report Number: 0001625425-2023-01029
• Device Sequence Number: 6046938
• Product Code: IZI
• UDI-Device Identifier: 00886333207213
• UDI-Public: 00886333207213
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K911732
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/25/2023

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: 193210
• Device Catalogue Number: 193210
• Device Lot Number: 11463090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2023
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 05/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown