MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. L-CATH PICC S/L 28GA

Catalog Number 384516

Device Problem Occlusion Within Device (1423)

Patient Problem Venipuncture (2129)

Event Date 01/22/2016

Event Type  malfunction  

Manufacturer Narrative

No lot number was provided in relation to this complaint; therefore, the device history record could not be reviewed.According to the complaint form, no product is available for return to argon quality in connection with this complaint.Without the return of the product, and with no lot number to review, a definitive cause for the occlusion of the catheter could not be determined.Catheter occlusion can be related to kinks or bends in the catheter under the dressing, conditions in the patient's body, drug and mineral precipitation in the catheter, or the development of thrombus.L-cath catheters are 100% visually inspected at various points in the manufacturing process and 100% leak and flow tested.Control catheters are also tested for tensile strength.

Event Description

Pt had picc placed over the weekend (refer to problem/event date) which could have been (b)(6) 2016.Picc line clotted sometime during the weekend.Clotted picc removed.A second picc had to be placed in this patient.Lot# unavailable/no product available for return.

• Brand Name: L-CATH PICC S/L 28GA
• Type of Device: L-CATH
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 1445 flat creek road; athens TX 75751
• Manufacturer (Section G): ARGON MEDICAL DEVICES, INC.
• Manufacturer Contact: gail smith ; 1445 flat creek road; athens, TX 75751 ; 2144368995
• MDR Report Key: 5448389
• MDR Text Key: 39043910
• Report Number: 1625425-2015-00082
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020834
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 384516
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1