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

Model Number	193210
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	Insufficient Information (4580)
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
Multiple issues reported of 12cc syringe drawing in air during manifold prep.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no similar concerns were found.After three notifications, there have been no samples returned.However, 87 samples for the same lot were received for cc 15580.The investigation results for cc 15580 will be used for this complaint.87 samples were returned for review for cc 15580, 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 of the sealed samples were reviewed and tested with no leakage issues observed.Fi-2023-00032 was initiated for this issue.Per the fi, the most probable cause for the reported issue was most likely related to a potential lack of control limits on the injection molding parameters which allows for dimensional variation.Internal corrective actions will be assigned and completed through fi-2023-00032.

• Brand Name: 12CC CONTROL SYRINGE FR/TR/RA W/RESERVOIR
• Common Device Name: 12CC CONTROL SYRINGE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek road; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek road; athens, TX 75751 ; 9036759321
• MDR Report Key: 19580939
• Report Number: 0001625425-2024-01047
• Device Sequence Number: 3340525
• Product Code: IZI
• UDI-Device Identifier: 00886333207213
• UDI-Public: (01)00886333207213(17)271003(10)11441141
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2024

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 Lot Number: 11441141
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2024
• Supplement Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 08/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2022
• 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
• Patient Sex: Unknown