MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. 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	02/20/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a free-floating particle was discovered in the final product bag.This defect was discovered during visual inspection of the final product bag during final product packaging.The particle was isolated and identified using a fourier transform infrared spectroscopy and scanning electron microscopy.The report indicated that the particle (s1) was characterized to be consistent with chlorinated polyolefin (polyethylene).The most intense peaks are the silicate si-o and si-o-si peaks at 1031 and 1007 cm-1.The relatively intensity of the methylene (ch2) peak at 1443 cm-1 indicates the hydrocarbon is highly chlorinated.The ester peak at 1726 cm-1 is a relatively minor component as indicated by its low intensity and is likely an additive or minor degradation product.
Additional Manufacturer Narrative
No product was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.If the product is returned, the manufacturer will reopen this complaint for further investigation.
Additional Manufacturer Narrative
The product was not returned for evaluation a lot history review was performed and no nonconformances or complaint trending could be identified for this part number or lot number.The pictures submitted with the record do not show contamination in the fluid path and is not foreign material to the stopcock.The stopcock underwent further processing at customer site.Without the benefit of samples, it can't be confirmed when, where, or how this material ended up in the final stopcock packaging.The defect was noticed after final packaging and there is no report of discovery of the defect upon initial receipt at the customer site.The defect cannot be confirmed.

• Brand Name: MEDEX 3-WAY STOPCOCK
• Common Device Name: STOPCOCK, I.V. SET
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6250 shier rings road; dublin OH 43016
• Manufacturer Contact: reed covert ; 6250 shier rings road; dublin, OH 43016 ; 2247062300
• MDR Report Key: 22089270
• Report Number: 1526863-2025-00061
• Device Sequence Number: 6947598
• Product Code: FMG
• UDI-Device Identifier: 10351688506795
• UDI-Public: (01)10351688506795(17)270304(10)4470075
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: UNKNOWN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2025

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: 4470075
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: 06/13/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/30/2024
• 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