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

Model Number 756514025

Device Problem Fluid/Blood Leak (1250)

Patient Problems Fluid Discharge (2686); Insufficient Information (4580)

Event Date 01/11/2023

Event Type  malfunction  

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 Description

Fluid leakage of patients with nephrostomy on the second day after operation.

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.Visual inspection of the sample returned from the customer did not find any damage of the product.Device was functionally tested and leakage was observed through the string hole confirming the complaint.According to the procedure mp-208 revision 9, during the manufacturing, operator follow these guidelines to complete the manufacture process: 1.Insert the sleeve into the hub until the pickup tool touches the hub.2.Upon insertion, the glue is scraped to the outside of the hub, ready to be set by the uv light source.3.Place a small puddle of uv light cure glue on a disposable poly bag.4.Pull and hold the suture strings and place the hub into the hub gluing tool#: 164-017-b1.5.Apply the glue to the inside of the suture sleeve.6.Pick up a second dab of glue and place it on the top of the sleeve hole, between the suture strings.7.Hold the glued side towards the light source and the hub against the bottom of the light shade.8.Step on the activation pedal, exposing the uv light to the glue for at least 6 seconds.Wait a few seconds for the glue to set.9.Check the functionality of the suture mechanism by straightening out and closing the pigtail a few times.The string mechanism should work freely.Argon quality manger and area supervisor have been notified of this issue and training was provided to ensure operator understanding of the procedure and prevent this issue in the future.

Event Description

Fluid leakage of patients with nephrostomy on the second day after operation.

• Brand Name: SKATER ALL-PURPOSE DRAINAGE CATHETER LOCKING PIGTAIL 14FR X 25CM
• Type of Device: 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: 16187715
• MDR Text Key: 308726895
• Report Number: 0001625425-2023-00940
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/28/2023

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
• Device Model Number: 756514025
• Device Lot Number: 11439628
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/11/2023
• Initial Date FDA Received: 01/17/2023
• Supplement Dates Manufacturer Received: 01/11/2023
• Supplement Dates FDA Received: 02/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other