MAUDE Adverse Event Report: ARGON MEDICAL DEVICES CLEAR 4-WAY STOPCOCK W/ MALE LUER LOCK

Model Number	041210002A
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample is indicated as available for return, as of this date, sample has not been returned.A follow-up report will be submitted once the sample has been received and reviewed.
Event or Problem Description
Blood is leaking out at stopcock during open heart procedures making a mess.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and similar concerns were found.After three notifications, there has been no samples returned for review for ln 11432919.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.However, due to the number of similar complaints regarding lower- level lot numbers for the stopcock body, this complaint is confirmed.A definite root cause for the leakage could not be determined without the sample to review.A possible root cause is that there was a partial occlusion in one of the stopcock body ports which under pressure resulted in leakage.Another possible root cause could be related to damage to the stopcock body when the core/handle was assembled.Possibly the assembly caused a crack in the stopcock body.The stopcock bodies are being 100% inspected for occlusions and the assembly of the stopcock body and the core/handle are being 100% leak tested until this issue has been resolved.
Event or Problem Description
Blood is leaking out at stopcock during open heart procedures making a mess.

• Brand Name: CLEAR 4-WAY STOPCOCK W/ MALE LUER LOCK
• Common Device Name: STOPCOCK
• 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: 15613073
• Report Number: 0001625425-2022-01113
• Device Sequence Number: 12780682
• Product Code: DTL
• UDI-Device Identifier: 00886333201389
• UDI-Public: 00886333201389
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K780271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2022

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
• Device Model Number: 041210002A
• Device Catalogue Number: 041210002A
• Device Lot Number: 11432919
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2022
• Supplement Date Received by Manufacturer: 10/07/2022
• Initial Report FDA Received Date: 10/16/2022
• Supplement Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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