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

Model Number	041210002A
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is indicated as available for evaluation.Argon has made three efforts in requesting the return of the device.As of the date of this report, it has not been returned.Without such evidence, the complaint cannot be confirmed.If additional information is received in the future, a follow-up report will be provided.
Event or Problem Description
Stopcock was placed on the distal end of iv tubing infusing propofol 2% to facilitate line changes q 12 h.The other port was connected to a manifold infusing ns and fentanyl and then connected to one lumen of a triple lumen catheter, as per standard of care.After approximately 24 -48 hours of use the stopcock was noted to be leaking blood and propofol from the connection site.There was no evidence of cracks or damage to the stopcock or tubing.Both changed and patient stable throughout.
Additional Manufacturer Narrative
H3 other text: placeholder.
Event or Problem Description
Follow up.

• Brand Name: 4-WAY STOPCOCK W/MALE LUER LOCK
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 10950570
• Report Number: 1625425-2020-00743
• Device Sequence Number: 4329882
• Product Code: DTL
• UDI-Device Identifier: 00886333201389
• UDI-Public: 00886333201389
• Combination Product (Y/N): N
• PMA/510(K) Number: K780271
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/17/2025
• Device Model Number: 041210002A
• Device Catalogue Number: 041210002A
• Device Lot Number: 11316959
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2020
• Supplement Report FDA Received Date: 01/14/2021
• 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