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

Model Number 384221

Device Problems Material Frayed (1262); Dull, Blunt (2407)

Patient Problems Laceration(s) (1946); Unspecified Tissue Injury (4559)

Event Type  malfunction  

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 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.

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 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
• Type of Device: 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
• MDR Text Key: 309589389
• Report Number: 0001625425-2023-00969
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00886333209743
• UDI-Public: 00886333209743
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K972262
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other