MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. SKATER ALL PURPOSE AND NEPHROSTOMY DRAINAGE SET; CATHETER, NEPHROSTOMY, GENERAL PLASTIC SURGERY

Catalog Number	75660830
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The skater drain chest tube was placed on [date redacted].Removal of the chest tube a week later resulted in retention of the retention string.Multiple attempts to remove the string were unsuccessful.It was removed the next morning by a surgeon at the bedside.

• Brand Name: SKATER ALL PURPOSE AND NEPHROSTOMY DRAINAGE SET
• Common Device Name: CATHETER, NEPHROSTOMY, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): ARGON MEDICAL DEVICES, INC.; 1445 flat creek rd.; athens TX 75751
• MDR Report Key: 19655043
• Report Number: 19655043
• Device Sequence Number: 6914356
• Product Code: GBO
• UDI-Device Identifier: 00886333217793
• UDI-Public: (01)00886333217793
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 06/05/2024
• Report Date (Section F): 06/05/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 75660830
• Device Lot Number: 11561295
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/02/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 06/05/2024