MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS; CVC DRESSING CHANGE KIT

Catalog Number	EBSI1184
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility, on (b)(6) 2025, cvc "kit opened on another day, one of the normal saline syringes were cracked and no saline noted." 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.
Event or Problem Description
According to the facility, cvc "kit opened on another day, one of the normal saline syringes were cracked and no saline noted.".

• Common Device Name: CVC DRESSING CHANGE KIT
• 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: 22794747
• Report Number: 3004519921-2025-00034
• Device Sequence Number: 15525425
• Product Code: LRO
• UDI-Device Identifier: 10888277736511
• UDI-Public: 10888277736511
• 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): 08/13/2025

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 Catalogue Number: EBSI1184
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2025
• Initial Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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