MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS MEDLINE; 7FR 3L 16CM CVC INSERTION BUNDLE

Catalog Number	ECVC8215
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility, on (b)(6) 2026, a central line was being placed by the surgeon, and the needle hub was found to have a crack at the base, therefore unable to draw suction from the syringe.The item was removed from service and sequestered.Per the facility, the crack was found after the insertion of the needle, and the patient required a re-stick.The central line was then completed with a new kit.No report of any adverse health effects or medical intervention required.No additional information at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this is a reportable event.If additional information becomes available this report will be reopened and reevaluated.
Event or Problem Description
According to the facility, on (b)(6) 2026, a central line was being placed by the surgeon, and the needle hub was found to have a crack at the base, therefore unable to draw suction from the syringe.

• Brand Name: MEDLINE
• Common Device Name: 7FR 3L 16CM CVC INSERTION BUNDLE
• 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: 24381914
• Report Number: 3004519921-2026-00004
• Device Sequence Number: 10208227
• Product Code: OES
• UDI-Device Identifier: 10653160358992
• UDI-Public: 10653160358992
• 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): 02/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ECVC8215
• Device Lot Number: 2025101790
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2026
• Initial Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 91 KG