MAUDE Adverse Event Report: ICU MEDICAL, INC MEDEX HI-FLO 4-WAY STOPCOCK W/MALE LUER LOCK; STOPCOCK, I.V. SET

Catalog Number	MX4341L
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: date of event is unknown; no information has been provided to date.H3: device not returned to manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
Event or Problem Description
It was reported that luer lock is slipping with the syringe.The reporter stated when they placed a syringe on the end and twisted to lock in place, the luer lock kept clicking and never truly locked the syringe in place.Patient involvement was unknown.
Additional Manufacturer Narrative
D3.Mfg name: corrected the device was not returned for evaluation.Lot: 6072510 was released from manufacturing and there are no associated nonconformances with this lot, and no trending could be identified for this part or lot number.No sample nor photo of the reported defect were submitted with the complaint record.With no evidence of the defect, the defect could not be confirmed.

• Brand Name: MEDEX HI-FLO 4-WAY STOPCOCK W/MALE LUER LOCK
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL, INC; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: reed covert ; 6250 shier rings road; dublin, OH 43016 ; 2247062300
• MDR Report Key: 21909508
• Report Number: 1526863-2025-00045
• Device Sequence Number: 19879697
• Product Code: FMG
• UDI-Device Identifier: 10351688507648
• UDI-Public: (01)10351688507648(17)271120(10)6072510
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2025

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 Catalogue Number: MX4341L
• Device Lot Number: 6072510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2025
• Supplement Date Received by Manufacturer: 06/29/2025
• Initial Report FDA Received Date: 04/25/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2024
• 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