MAUDE Adverse Event Report: ARGON MEDICAL DEVICES FIRSTSTIC N INTRODUCER 26GA (1.9F) O.D (1.1MM) I.D (0.7MM) L (19MM)

Model Number	384062
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	12/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
"after the second puncture, the introducer is worn out and a new puncture with the same introducer is not possible, causing injury to the patient's skin".
Additional Manufacturer Narrative
According to the product experience report, there was no sample to be returned.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without such evidence, this complaint could not be confirmed and determining a definite root cause and corrective action is not possible.If the sample is returned at a future date, a follow-up report will be submitted.

• Brand Name: FIRSTSTIC N INTRODUCER 26GA (1.9F) O.D (1.1MM) I.D (0.7MM) L (19MM)
• Common Device Name: INTRODUCER
• 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: 16132934
• Report Number: 0001625425-2023-00925
• Device Sequence Number: 15355443
• Product Code: DYB
• UDI-Device Identifier: 00886333217717
• UDI-Public: 00886333217717
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K141969
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 01/10/2023

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?: No
• Device Model Number: 384062
• Device Catalogue Number: 384062
• Device Lot Number: 11433586
• Was Device Available for Evaluation?: No
• 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: 12/28/2022
• Initial Report FDA Received Date: 01/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2022
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown