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

Model Number 193210

Device Problem Air/Gas in Device (4062)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/20/2023

Event Type  malfunction  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 313504436
• Report Number: 0001625425-2023-01029
• Device Sequence Number: 1
• Product Code: IZI
• UDI-Device Identifier: 00886333207213
• UDI-Public: 00886333207213
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K911732
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/05/2023
• Initial Date FDA Received: 04/18/2023
• Supplement Dates Manufacturer Received: 04/05/2023
• Supplement Dates FDA Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/14/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other