MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SKATER ALL PURPOSE AND NEPHROSTOMY DRAINAGE SET LOCKING 8F X 35CM

Model Number	756608035
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer experienced leakage from catheter, from the hole were the string comes out during the procedure.The customer was forced to change the catheter over the wire.The customer has used skater for a long time and has not experienced this before.They experienced 4 occasions with trouble of leakage.The customer decided to remove rest of products from the batch.
Additional Manufacturer Narrative
The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.
Additional Manufacturer Narrative
The sample is indicated as returned.As of the date of this report, the sample has not been evaluated.A follow-up report will be provided once the device has been reviewed.
Event or Problem Description
The customer experienced leakage from catheter, from the hole were the string comes out during the procedure.The customer was forced to change the catheter over the wire.The customer has used skater for a long time and has not experienced this before.They experienced 4 occasions with trouble of leakage.The customer decided to remove rest of products from the batch.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no deviations or non-conformances were found.A review of returned product from the customer was performed.Customer returned seven (7) unopened devices and one (1) open device.All eight devices returned from the customer was visually inspected and no damage was identified on the devices.Devices were functionally tested by performing a leak test but no leakage was found and the product complaint mode could not be duplicated and the complaint was not confirmed.Manufacturing defect could not be confirmed, so no further evaluation is needed at this time.No corrective action is required at this time either because a manufacturing defect could not be confirmed.
Event or Problem Description
The customer experienced leakage from catheter, from the hole were the string comes out during the procedure.The customer was forced to change the catheter over the wire.The customer has used skater for a long time and has not experienced this before.They experienced 4 occasions with trouble of leakage.The customer decided to remove rest of products from the batch.

• Brand Name: SKATER ALL PURPOSE AND NEPHROSTOMY DRAINAGE SET LOCKING 8F X 35CM
• 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: 16496280
• Report Number: 0001625425-2023-00988
• Device Sequence Number: 12185272
• Product Code: GBO
• UDI-Device Identifier: 00886333225132
• UDI-Public: 00886333225132
• Combination Product (Y/N): N
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/20/2023
• 2 Devices were Involved in the Event: 1 2

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: 756608035
• Device Catalogue Number: 756608035
• Device Lot Number: 11440399
• 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: 02/23/2023
• Supplement Date Received by Manufacturer: 02/23/2023; 02/23/2023
• Initial Report FDA Received Date: 03/07/2023
• Supplement Report FDA Received Date: 03/21/2023; 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/26/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown