MAUDE Adverse Event Report: ARGON MEDICAL DEVICES 4-WAY STOPCOCK W/ MLL; STOPCOCKS

Model Number 03-452004000

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 07/06/2021

Event Type  malfunction  

Manufacturer Narrative

The samples are unavailable for evaluation.Without such evidence to review, the complaint cannot be confirmed.If additional information is received in the future, a follow-up report will be submitted.

Event Description

Customer reported leaking in 9 of 120 units.(this just serves as a notification.).

• Brand Name: 4-WAY STOPCOCK W/ MLL
• Type of Device: STOPCOCKS
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: gina liu ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 12206988
• MDR Text Key: 264949424
• Report Number: 0001625425-2021-01039
• Device Sequence Number: 1
• Product Code: FMG
• 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
• Report Date: 07/21/2021

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 Operator: Health Professional
• Device Model Number: 03-452004000
• Device Lot Number: 11321418
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/06/2021
• Initial Date FDA Received: 07/21/2021
• 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
• Type of Device Usage: N
• Patient Sequence Number: 1