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

Model Number 193210

Device Problems Fluid/Blood Leak (1250); Air/Gas in Device (4062)

Patient Problems Low Blood Pressure/ Hypotension (1914); Pain (1994)

Event Date 02/16/2023

Event Type  Injury  

Event Description

Potential serious adverse event.Occurred during patient use ¿ approximately within 10 minutes of product use.Patient injury reported: severe transient hypotension, chest pain, and st elevation.Medical intervention: application of oxygen therapy, iv fluid bolus, administration of narcotic.During an angiogram procedure, scrub rn informed md that there was air/bubbles in the contrast injector syringe while pulling contrast when connected to the manifold.Next, investigated connections between the contrast bottle, contrast tubing, manifold and control syringe.No air nor bubbles present in the line from contrast bottle to the manifold.Once manifold and contrast syringe is cleared of air, if system remains closed, there should be no air present.The system was cleared multiple times and checked for air.No air was noted.Thereafter, dr instructed the scrub rn to inject contrast to view more pictures and right after, air was injected to the patient's coronary artery.An air emboli was noticed on x-ray and the patient reported chest discomfort.Patient's hemodynamics also changed -- st elevation and decreased blood pressure.Appropriate care provided to the patient.

Event Description

Potential serious adverse event occurred during patient use ¿ approximately within 10 minutes of product use.Patient injury reported: severe transient hypotension, chest pain, and st elevation medical intervention: application of oxygen therapy, iv fluid bolus, administration of narcotic during an angiogram procedure, scrub rn informed md that there was air/bubbles in the contrast injector syringe while pulling contrast when connected to the manifold.Next, investigated connections between the contrast bottle, contrast tubing, manifold and control syringe.No air nor bubbles present in the line from contrast bottle to the manifold.Once manifold and contrast syringe is cleared of air, if system remains closed, there should be no air present.The system was cleared multiple times and checked for air.No air was noted.Thereafter, dr instructed the scrub rn to inject contrast to view more pictures and right after, air was injected to the patient's coronary artery.An air emboli was noticed on x-ray and the patient reported chest discomfort.Patient's hemodynamics also changed -- st elevation and decreased blood pressure.Appropriate care provided to the patient.

Manufacturer Narrative

A review of the dhr and inspection records was conducted, and no similar concerns were found.87 samples were returned for review with one of those returned with signs of use.The analyst and the area supervisor visually inspected the used sample and no cracks were visible, however, a clear gel like substance was found under the rotating adapter, possibly left from the user environment.The sample was functionally tested by pulling colored water into the syringe and capping off the distal tip of the syringe.The plunger was pushed and leakage was confirmed just below the rotating adapter in the same area the clear gel like substance was observed.The area was examined using magnification and a gap was found in the mold parting line of the syringe that would result in leakage.Five random sealed samples were reviewed and tested with no leakage issues observed.The most probable cause for the gap in the mold parting line of the syringe was most likely due to an error in the molding process.An investigation into a definite root cause is currently being conducted and corrective actions will be determined based on the findings of the investigation.

Manufacturer Narrative

The sample is indicated as returned.As of the date of this report, the sample has not been evaluated.A follow-up report will be provided once the device has been reviewed.

Event Description

Potential serious adverse event occurred during patient use ¿ approximately within 10 minutes of product use.Patient injury reported: severe transient hypotension, chest pain, and st elevation medical intervention: application of oxygen therapy, iv fluid bolus, administration of narcotic during an angiogram procedure, scrub rn informed md that there was air/bubbles in the contrast injector syringe while pulling contrast when connected to the manifold.Next, investigated connections between the contrast bottle, contrast tubing, manifold and control syringe.No air nor bubbles present in the line from contrast bottle to the manifold.Once manifold and contrast syringe is cleared of air, if system remains closed, there should be no air present.The system was cleared multiple times and checked for air.No air was noted.Thereafter, dr instructed the scrub rn to inject contrast to view more pictures and right after, air was injected to the patient's coronary artery.An air emboli was noticed on x-ray and the patient reported chest discomfort.Patient's hemodynamics also changed -- st elevation and decreased blood pressure.Appropriate care provided to the patient.

• 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: 16501963
• MDR Text Key: 310871923
• Report Number: 0001625425-2023-00994
• 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: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 04/25/2023

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
• Device Operator: Health Professional
• Device Model Number: 193210
• Device Catalogue Number: 193210
• Device Lot Number: 11441141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/01/2023
• Initial Date FDA Received: 03/08/2023
• Supplement Dates Manufacturer Received: 03/01/2023; 03/01/2023
• Supplement Dates FDA Received: 04/10/2023; 04/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other