MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS; PORT ACCESS TRAY

Catalog Number	DT21830B
Medical Device Problem Codes	Break (1069); Material Integrity Problem (2978)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the facility, when the nurse was accessing a patient's port, "rn went to try and flush the port.Upon flushing the port after verifying blood return the finger hold on to the flush cracked off.This resulted in the plastic on the syringe cutting through the sterile gloves and causing a cut to the rn right index finger." per the facility, patient's port was exposed longer than needed, however "nothing happened." for the user, "no follow up care needed.Washed wound with soap and water and covered with band aide.Monitored for s/s of infection.Wound is healed." facility also reports "plunger retracts all the way out of the barrel.".
Additional Manufacturer Narrative
According to the facility, when the nurse was accessing a patient's port, "rn went to try and flush the port.Upon flushing the port after verifying blood return the finger hold on the flush cracked off.This resulted in the plastic on the syringe cutting through the sterile gloves and causing a cut to the rn right index finger." per the facility, patient's port was exposed longer than needed, however "nothing happened." for the user, "no follow up care needed.Washed wound with soap and water and covered with band aide.Monitored for s/s of infection.Wound is healed." facility also reports "plunger retracts all the way out of the barrel." no additional information 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 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 TRAY
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS; tri-state de mexico, s. de r.l; mexicali baja california, 21397 ; MX 21397
• Manufacturer Contact: alyssa reasner ; 3 lakes dr; northfield, IL 60093
• MDR Report Key: 23582070
• Report Number: 3004519921-2025-00039
• Device Sequence Number: 9533154
• Product Code: LRP
• UDI-Device Identifier: 10653160353461
• UDI-Public: 10653160353461
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 11/18/2025

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: DT21830B
• Device Lot Number: 2025082590
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2025
• Initial Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2025
• 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