MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS CORPORATION MEDLINE INDUSTRIES, INC.; CARDIAC CATHETERIZATION KIT

Model Number	ECVC1525
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Event 1 [date redacted] lot: 2025030690: placement of central line catheter - vantex cvc [central venous catheter] antimicrobial 3 lumen, 7fr, 20cm, lot #2025030690.Successful placement of cvc, confirmed by xr [x-ray] terminating in the svc.Blood return not present on blue and white lumen, minimally present on brown port with positioning and laying patient supine.Event 2 [date redacted] lot: n/a: no blood return from white port of tlc [triple lumen catheter] lined placed [date redacted].Event 3 [date redacted] lot: 2025030690: vantex left femoral tlc inserted [date redacted].No blood return documented by rn on medial (blue) and proximal (white) ports.Upon assessment this morning unable to draw back on either port but infusing with no issues.Event 4 [date redacted] lot: 2025030690: vantex tlc insertion per provider, no blood return on distal brown port on insertion per provider and note.Rn had no blood return on distal brown port either.Provider also noted during insertion the needle fell off the suture line.Unable to finish needed a supplemental suture kit to complete.Event 5 [date redacted] lot: n/a: patient had a right intrajugular triple lumen catheter (tlc) that lost blood return from all three lumens.All lumens were flushing without difficulty, but when aspirated for blood return there was none.Manufacturer response for vantex tlc, vantex tlc (per site reporter).Medline came on site [date redacted].Events being tracked by team.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: CARDIAC CATHETERIZATION KIT
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS CORPORATION; 301 catrell dr; howell MI 48843
• MDR Report Key: 22663921
• Report Number: 22663921
• Device Sequence Number: 3716075
• Product Code: OES
• UDI-Device Identifier: 10653160334545
• UDI-Public: (01)10653160334545
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/10/2025
• Report Date (Section F): 07/10/2025

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 Model Number: ECVC1525
• Device Catalogue Number: ECVC1525
• Device Lot Number: 2025030690
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/30/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/30/2025
• 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
• Date Report Sent to FDA: 07/10/2025