MAUDE Adverse Event Report: ARGON MEDICAL DEVICES FIRST PICC S/L BASIC KIT 26GA (1.9F) X 50CM 1 LUMEN

Model Number	384221
Medical Device Problem Codes	Material Frayed (1262); Dull, Blunt (2407)
Health Effect - Clinical Codes	Laceration(s) (1946); Unspecified Tissue Injury (4559)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample is not available for return.Customer provided images and videos for investigation.A follow-up report will be submitted once investigation is completed.
Event or Problem Description
When performing the puncture, the tip of the introducer is blunt, injuring the patient, not allowing a new adequate puncture.In other punctures, it was lacerated, with irregular edges and when reinserting it, it was possible to feel (as reported by the professionals) that it was injuring the tissue, rupturing the patients vein (see attached photo).The patients with picc passage criteria are extreme premature and with fragile venous net, the fact caused damage to the patients, increasing the risks and exposing the nb unnecessarily, sometimes the procedure was given up for insertion of another catheter.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no similar concerns were found.According to the product experience report, there was no sample available for review.However, images and a video were provided.A review of the video and images found that there appeared to be damage to the distal end of the plastic protective sheath that covers the needle.The edges appeared to be jagged.The needle tip could not be seen clearly in the provided images.Therefore, this complaint will be confirmed for damage to the protective sheath.A definite root cause for the damage to the plastic protective sheath could not be established with confidence as it could not be determined if the damage occurred during unit storage of the product, assembly of the kit, or in the user environment.The ifu states not to use if damaged.There have been no other complaints regarding this issue with this part number or lot number, therefore, 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
When performing the puncture, the tip of the introducer is blunt, injuring the patient, not allowing a new adequate puncture.In other punctures, it was lacerated, with irregular edges and when reinserting it, it was possible to feel ( as reported by the professionals) that it was injuring the tissue, rupturing the patients vein ( see attached photo).The patients with picc passage criteria are extreme premature and with fragile venous net, the fact caused damage to the patients, increasing the risks and exposing the nb unnecessarily, sometimes the procedure was given up for insertion of another catheter.

• Brand Name: FIRST PICC S/L BASIC KIT 26GA (1.9F) X 50CM 1 LUMEN
• Common Device Name: FIRST PICC
• 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: 16373161
• Report Number: 0001625425-2023-00969
• Device Sequence Number: 15044593
• Product Code: PND
• UDI-Device Identifier: 00886333209743
• UDI-Public: 00886333209743
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K972262
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2023
• 2 Devices were Involved in the Event: 1 2

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 Expiration Date: 09/14/2024
• Device Model Number: 384221
• Device Catalogue Number: 384221
• Device Lot Number: 11389377
• Was Device Available for Evaluation?: No
• 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: 02/07/2023
• Supplement Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2021
• 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