MAUDE Adverse Event Report: ARGON MEDICAL DEVICES DRAINAGE BAG CONNECTING TUBE MALE-TWS/FUNNEL 15CM - 50PSI

Model Number 404343015

Device Problem Disconnection (1171)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/12/2022

Event Type  malfunction  

Manufacturer Narrative

It is unknown if the sample will get returned for evaluation or not.A follow-up report will be submitted once more information becomes available.It is unknown if the sample will get returned to argon or not.

Event Description

Two cases occurred after implantation of the drain, where the drain connection tube spontaneously disconnect from the male luer lock.They have only reported one case but say they have experienced it twice.There is a risk for the patient if this happened and nobody is aware immediately.

Manufacturer Narrative

A review of the dhr and inspection records was conducted, and no similar concerns were found.Correspondence from the customer related that there was no sample available to return for review.However, images were provided that were consistent with the reported issue.Therefore, this complaint was confirmed based on the provided images.Without the sample to review, determining a definite root cause for the detachment is not possible.There have been no other complaints regarding this issue with this part number or lot number.The reported issue was most likely an isolated event.Since a definite root cause could not be established and there have been no other complaints regarding this issue with this lot number, no corrective action will be taken at this time.Argon will continue to monitor for issues of this nature in the future.

Event Description

Two cases occurred after implantation of the drain, where the drain connection tube spontaneously disconnect from the male luer lock.They have only reported one case but say they have experienced it twice.There is a risk for the patient if this happened and nobody is aware immediately.

• Brand Name: DRAINAGE BAG CONNECTING TUBE MALE-TWS/FUNNEL 15CM - 50PSI
• Type of Device: DRAINAGE BAG
• 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: 15613103
• MDR Text Key: 306986172
• Report Number: 0001625425-2022-01114
• Device Sequence Number: 1
• Product Code: KGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 404343015
• Device Lot Number: 11421066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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