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

Model Number	193210
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample is unavailable for evaluation.Without such evident to review, the complaint cannot be confirmed.If additional information is provided in the future, a follow-up report will be submitted.
Event or Problem Description
During procedure, a physician was unable to push/pull the plunger due to high resistance.The procedure was completed by using an additionally opened replacement (193210).As a result of the returned sample(s) review at gmk: the syringe tip was blocked by something, and high resistance to pull the plunger was confirmed, before cleaning of the sample.It was disappeared, after cleaning of the sample.
Additional Manufacturer Narrative
A review of the dhr and inspection records could not be conducted since a lot number was not provided.One opened sample was returned for review.Images of the reported issue were also provided by the customer.Evidence of a unknown substance was visible both in the images provided and on the returned sample.Examination of the returned sample found a yellow unknown substance along the plunger and around the rim of the plunger collar.It was stated that the syringe blockage disappeared after it was cleaned.The syringe was tested by the analyst and the syringe functioned as designed with only slight resistance from the presence of the yellow unknown substance along the plunger.Therefore, this complaint could not be confirmed for a manufacturing error.The most probable cause for the experienced resistance/blockage was most likely the result of an event within the user environment in which the plunger was exposed to the yellow unknown substance as it was stated the resistance occurred during the procedure.Since the reported issue was most likely the result of an event within the user environment and not a manufacturing error, no corrective action will be taken at this time.Argon will continue to monitor for issues of this nature in the future.
Event or Problem Description
During procedure, a physician was unable to push/pull the plunger due to high resistance.The procedure was completed by using an additionally opened replacement(193210).As a result of the returned sample(s) review at gmk: -the syringe tip was blocked by something, and high resistance to pull the plunger was confirmed, before cleaning of the sample.-it was disappeared, after cleaning of the sample.

• 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 rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 13280659
• Report Number: 0001625425-2022-00932
• Device Sequence Number: 17412132
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2022

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2022
• Supplement Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 01/18/2022
• Supplement Report FDA Received Date: 02/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown