MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SKATER ALL-PURPOSE AND NEPHROSTOMY SET LOCKING 8FR X 25CM

Model Number 756608025

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 03/16/2024

Event Type  Injury  

Event Description

Complications of pulling a pleural drain.Three patients who received a pleural drain 2 of 3.(b)(6) where the pleural drain was pulled in the evening.It was removed according to the pm but could not be removed.The black thin wires were stuck.Left with a drain halfway out.Anesthesiologists or back-up medicine were busy.(b)(4) said we should cut one of two thin black wires.It was still impossible to pull out.In the end we call rtg who can help us.According to their answer, they had to cut open the drain pipes themselves so that the threads became visible and somehow pry/pull so that the threads release.The drain itself is no problem to pull out.

Manufacturer Narrative

The sample is not available for return.The investigation is currently in progress.A follow-up report will be submitted upon investigation completion.

• Brand Name: SKATER ALL-PURPOSE AND NEPHROSTOMY SET LOCKING 8FR X 25CM
• Type of Device: SKATER
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 19189335
• MDR Text Key: 341117188
• Report Number: 0001625425-2024-01000
• Device Sequence Number: 1
• Product Code: GBO
• UDI-Device Identifier: 00886333217786
• UDI-Public: 00886333217786
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 756608025
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/27/2024
• Initial Date FDA Received: 04/26/2024
• 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
• Patient Outcome(s): Required Intervention