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

Catalog Number 384539

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The complainant did not indicate if the sample device is available for evaluation.A follow-up report will be provide by 4/3/2020 in anticipation of a response to the requests for the return of the device.

Event Description

Please ship no charge replacement product to the following address: (b)(6).*strain relief slid out of the hub and down the indwelling portion of the picc.Picc cut below strain relief by nurse and repaired so the picc may continue to be utilized.*per (b)(6) -value analysis --- risk management will notify him if the product may or may not be returned to argon quality.If product is released by risk management, a document will need to be signed prior to release by argon.

Manufacturer Narrative

Argon medical has made three good faith efforts in requesting the return of the device for evaluation.As of the date of this report, the device has not been returned.Without such evidence, the complaint cannot be confirmed.If additional information is received, a follow-up report will be provided.

• 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 INC.; 1445 flat creek road; athens TX 75751
• MDR Report Key: 9787978
• MDR Text Key: 185009287
• Report Number: 1625425-2020-00200
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): Y
• PMA/PMN Number: K091670
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 384539
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1