MAUDE Adverse Event Report: ICU MEDICAL, INC., DUBLIN OH MEDEX 3-WAY STOPCOCK; STOPCOCK, I.V. SET

Catalog Number	MX5311L
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 information becomes available.
Event or Problem Description
It was reported that a discrepant material was identified.Two (2) units with embedded particulates, one (1) unit with a blue speck within the fluid path, and ten (10) units with blue specks on the outer/non-product contact surface.There was no patient involvement.
Additional Manufacturer Narrative
H2) device evaluation: d3 manufacturer establishment name updated.D9 date returned to manufacturer: 4/28/2025.H6: the device was returned for root cause analysis and the investigation findings concluded after visual inspection and functional testing, and the customer problem was not duplicated.The device was found to have blue specks on the stopcocks that were not imbedded in the molded material or in the fluid path area.The products were unpackaged with the suspect contamination as superficial and easy to wipe off.The reported complaint could not be confirmed.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacturing.

• Brand Name: MEDEX 3-WAY STOPCOCK
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL, INC., DUBLIN OH; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: reed covert ; 6250 shier rings road; dublin, OH 43016 ; 2247062300
• MDR Report Key: 21971801
• Report Number: 1526863-2025-00050
• Device Sequence Number: 8260629
• Product Code: FMG
• UDI-Device Identifier: 10351688506795
• UDI-Public: (01)10351688506795(17)271209(10)6070440
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2025

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: MX5311L
• Device Lot Number: 6070440
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2025
• 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