MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SKATER ALL-PURPOSE AND NEPHROSTOMY DRAINAGE SET LOCKING 12FR X 25CM

Model Number	756612025
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is unavailable for return.Customer provided images to argon.A follow-up report will be submitted once the images have been reviewed.
Event or Problem Description
While placing the skater drainage catheter, the locking mechanism broke, cathter was removed and a new catheter had to be placed for the patient.
Event or Problem Description
While placing the skater drainage catheter, the locking mechanism broke, cathter was removed and a new catheter had to be placed for the patient.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted, and no deviations and non-conformances were recorded.A review of photos from the customer was performed, found locking tap was broken in the sealed pouch and the complaint was confirmed.The most probable root causes are final packaging, shipping, unit storage, mishandling by operator, after reaching the customer facility or damage prior to use.No corrective action is required at this time because a manufacturing defect could not be confirmed.

• Brand Name: SKATER ALL-PURPOSE AND NEPHROSTOMY DRAINAGE SET LOCKING 12FR X 25CM
• Common Device Name: SKATER
• 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: 15410715
• Report Number: 0001625425-2022-01086
• Device Sequence Number: 14830827
• Product Code: GBO
• UDI-Device Identifier: 00886333217847
• UDI-Public: 00886333217847
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2022

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 Model Number: 756612025
• Device Catalogue Number: 756612025
• Device Lot Number: 11435064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2022
• Supplement Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 09/13/2022
• Supplement Report FDA Received Date: 09/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown