MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. CENTURION MEDICAL PRODUCTS CORP; CATHETER CARE TRAY

Model Number CVI680C

Device Problem Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/10/2023

Event Type  malfunction  

Event Description

"central line being placed on patient.During procedure set up sterile probe cover placed from tlc kit and was noted to have a hole in it at the tip that gets applied to the patient's skin.Was able to take the probe cover off without breaking sterility and new sterile prob cover was placed.Probe cover obtained from tlc insertion tray from with lot# 22jbn103".

• Brand Name: CENTURION MEDICAL PRODUCTS CORP
• Type of Device: CATHETER CARE TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• MDR Report Key: 17315631
• MDR Text Key: 318940171
• Report Number: 17315631
• Device Sequence Number: 1
• Product Code: OHR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: CVI680C
• Device Catalogue Number: CVI680C
• Device Lot Number: 22JBN103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/26/2023
• Event Location: Hospital
• Date Report to Manufacturer: 07/13/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1