MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SKATER ALL PURPOSE AND NEPHROSTOMY DRAINAGE SET NON-LOCKING 7F X 25CM

Model Number	756107025
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the product experience report, there was no sample to be returned.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without such evidence, this complaint could not be confirmed and determining a definite root cause and corrective action is not possible.If the sample is returned at a future date, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2023, the patient underwent kidney puncture and drainage under b-ultrasound guidance due to hydronephrosis.After the doctor placed the tube successfully that day, he found that there was a crack at the interface of the drainage tube, which was covered by other parts before operation and could not be tested.The doctor immediately strengthened the fixation with adhesive tape for remedy, but there was a risk of increasing infection, and immediately reported adverse events.

• Brand Name: SKATER ALL PURPOSE AND NEPHROSTOMY DRAINAGE SET NON-LOCKING 7F 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: 16496153
• Report Number: 0001625425-2023-00986
• Device Sequence Number: 17716292
• Product Code: LJE
• UDI-Device Identifier: 00886333225507
• UDI-Public: 00886333225507
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/07/2023

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: 756107025
• Device Catalogue Number: 756107025
• Device Lot Number: 11440084
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2023
• Initial Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2022
• 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
• Patient Sex: Unknown