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

Model Number	041210002A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2024
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
Reporter indicated "when drawing blood through distal port of cvc, able to obtain small amount of blood, then bubbles.When flushing blood back into catheter, leak noted at stopcock.Linens near head noted to be damp and yellow-tinged, small amount.Stopcock replaced; line drew well after with no complications.Device had been changed on aug 7, so was not yet at the 96hr mark to be replaced.Venouse gases had been drawn from line q12hr from aug 7 to present.No apparent harm noted.Patient received less than anticipated amounts of infusions running through ij, including tpn, midazolam, and hydromorphone.".
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted and no similar concerns were found.After three notifications, there have been no samples returned for review.However, based on the number of complaints against this part number and lot number, this complaint will be confirmed.Engineering conducted an investigation to address the confirmed issues of stopcock leakage.The main factor that contributed to the opportunity for the product to have a potential leak involved the machine that inserts the stopcock core into the stopcock body.This machine could drift over time due to the vibration that comes from the feeding unit.This misalignment could cause the core to not be seated correctly inside the stopcock body and sometimes even damage the stopcock body resulting in leakage.A preventative action was initiated requiring maintenance to check the alignment of the mechanical device every production run.

• Brand Name: CLEAR 4-WAY STOPCOCK W/ MALE LUER LOCK
• Common Device Name: STOPCOCKS
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek road; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek road; athens, TX 75751 ; 9036759321
• MDR Report Key: 20201334
• Report Number: 0001625425-2024-01098
• Device Sequence Number: 20537023
• Product Code: DTL
• UDI-Device Identifier: 00886333201389
• UDI-Public: (01)00886333201389(17)271004(10)11441418
• Combination Product (Y/N): N
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2024

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
• Operator of Device: Health Professional
• Device Model Number: 041210002A
• Device Lot Number: 11441418
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/13/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown