MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SKATER DRAINAGE CATHETER - LOCKING PIGTAIL 8F X 25CM

Model Number	755108025
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the complaints database was conducted, and over the previous six months, no similar complaints were found related to the failure mode involving this part number.No similar complaints were found related to this lot number.A review of the manufacturing and inspection records for this lot was conducted.No deviations or non-conformances were found.One opened sample was returned from the customer for review.A visual inspection was performed on the returned product.The device was tested with the help of the manufacturers syringe for leakage without the purple luer and no leakage was observed.The complaint was not confirmed.No corrective action can be taken at this time since the issue cannot be replicated and also as we are not aware about the mating of device used with the product.
Event or Problem Description
The reporter indicated that following a percutaneous nephrostomy procedure, and the patient returning home, the pigtail's white connector hub leaked causing the patient's clothes to become wet.The patient returned to the hospital again to solve the leaked situation.The doctor stated the pigtail leaking issue continued to occur and had already used the purple luer but did not stop the leaking, they had no choice but to replace a new pigtail to solve the problem.
Additional Manufacturer Narrative
Udi related data quality updates only.

• Brand Name: SKATER DRAINAGE CATHETER - LOCKING PIGTAIL 8F X 25CM
• Common Device Name: SKATER DRAINAGE CATHETER
• 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: 19240311
• Report Number: 0001625425-2024-01007
• Device Sequence Number: 20706614
• Product Code: GBQ
• UDI-Device Identifier: 00886333000159
• UDI-Public: (01)00886333000159(17)280824(10)11494699
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2024

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
• Operator of Device: Health Professional
• Device Model Number: 755108025
• Device Lot Number: 11494699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2024
• Supplement Date Received by Manufacturer: 08/31/2024
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 08/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2023
• 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: Other
• Patient Sex: Unknown