MAUDE Adverse Event Report: PRODUCTOS MEDLINE; PORT ACCESS KIT

Catalog Number	CVI5010A
Medical Device Problem Codes	Crack (1135); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the facility, while attempting to flush a port with the syringe from the port access kit the flange snapped off the syringe.
Additional Manufacturer Narrative
According to the facility, while attempting to flush a port with the syringe from the port access kit the flange snapped off the syringe.No additional information was provided.The sample was requested for evaluation.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.In an abundance of caution, and in response to an fda 483 issued for cfn 1417592 on 22-jan-2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.

• Common Device Name: PORT ACCESS KIT
• Manufacturer (Section D): PRODUCTOS MEDLINE; productos medline s.a. de c.v.; blvd world trade center no. 10; nuevo laredo, tamaulipas 88285 ; MX 88285
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 23353540
• Report Number: 3004122598-2025-00012
• Device Sequence Number: 9019231
• Product Code: OEZ
• UDI-Device Identifier: 10195327695651
• UDI-Public: 10195327695651
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/21/2025

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: CVI5010A
• Device Lot Number: 25FBP063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown