MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - MEXICALI (MXC); PORT ACCESS KIT

Catalog Number	DYNDC3252C
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to facility on (b)(6) 2025 one of the syringes in the kit was missing markings, labels, and writing.There was no report of patient involvement or injury reported.No additional information is available at this time.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 (b)(4) on (b)(6) 2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
According to facility on (b)(6) 2025 one of the syringes in the kit was missing markings, labels, and writing.

• Common Device Name: PORT ACCESS KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - MEXICALI (MXC); calle circuito del desierto; parque industrial del desierto; mexicali, baja california 21383 ; MX 21383
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 22185321
• Report Number: 3015173212-2025-00001
• Device Sequence Number: 8617039
• Product Code: OFF
• UDI-Device Identifier: 10198459136108
• UDI-Public: 10198459136108
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 06/11/2025

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
• Device Expiration Date: 06/30/2026
• Device Catalogue Number: DYNDC3252C
• Device Lot Number: 24KME469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2024
• 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