MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SKATER DRAINAGE CATHETER - LOCKING PIGTAIL 14F X 25CM

Model Number	755114025
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
After placing the pigtail in the vivo the operators found the string port of the hub was keeping leaked.
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.
Event or Problem Description
After placing the pigtail in the vivo the operators found the string port of the hub was keeping leaked.
Additional Manufacturer Narrative
A review of the batch records confirmed that the product was manufactured according to specification and no deviations or anomalies were found.One opened device was returned for evaluation.Visual inspection found no damage to the product.Leak testing of the hub section found leakage at the suture sleeve.The most likely cause of the leakage at the suture sleeve was insufficient glue ((b)(6) ) applied inside the suture sleeve and between the suture strings.As corrective action, catheter assembly operators were provided awareness training regarding proper application of glue ((b)(6) ) inside suture sleeve and between suture strings.Training was completed on (b)(6) 2021.Parts for this lot were manufactured around (b)(6) of 2020.

• Brand Name: SKATER DRAINAGE CATHETER - LOCKING PIGTAIL 14F X 25CM
• Common Device Name: SKATER DRAINAGE CATHETER
• 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: 12987421
• Report Number: 0001625425-2021-01212
• Device Sequence Number: 11180903
• Product Code: GBQ
• UDI-Device Identifier: 00886333001194
• UDI-Public: 00886333001194
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2022

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 Expiration Date: 11/25/2025
• Device Model Number: 755114025
• Device Lot Number: 11339908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2021
• Supplement Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 12/13/2021
• Supplement Report FDA Received Date: 01/24/2022
• 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
• Patient Sex: Unknown