MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM

Model Number 384539

Device Problems Difficult to Remove (1528); Failure to Advance (2524)

Patient Problem Needle Stick/Puncture (2462)

Event Date 11/17/2022

Event Type  malfunction  

Event Description

The catheter seems stuck in a wall, impossible to push it into the vein, catheter very difficult to remove.Procedure had to be redone, different brand of catheter used, invasive technique for nn.

Manufacturer Narrative

Sample is not available for return.A follow-up report will be submitted once investigation has been completed.

Event Description

The catheter seems stuck in a wall, impossible to push it into the vein, catheter very difficult to remove.Procedure had to be redone, different brand of catheter used, invasive technique for nn.

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.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without such evidence, the results are inconclusive and determining a definite root cause and corrective action is not possible.

• Brand Name: L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM
• Type of Device: L-CATH 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: 16184381
• MDR Text Key: 308729226
• Report Number: 0001625425-2023-00934
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00886333209934
• UDI-Public: 00886333209934
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091670
• 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: 01/30/2023

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
• Device Operator: Health Professional
• Device Model Number: 384539
• Device Catalogue Number: 384539
• Device Lot Number: 11419018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/29/2022
• Initial Date FDA Received: 01/17/2023
• Supplement Dates Manufacturer Received: 12/29/2022
• Supplement Dates FDA Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention