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

Model Number S5078BF09

Device Problems Crack (1135); Leak/Splash (1354); Improper Flow or Infusion (2954)

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

Event Date 05/24/2023

Event Type  malfunction  

Event Description

This manifold device was involved in infusing medications.One port of manifold was noted to be cracked and leaking, affecting the delivery of medication to the patient.The device was removed.Manufacturer response for merit 4-port manifold, merit manifold (per site reporter).

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: CARDIAC CATHETERIZATION KIT
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS CORPORATION; 301 catrell dr; howell MI 48843
• MDR Report Key: 17266058
• MDR Text Key: 318461295
• Report Number: 17266058
• Device Sequence Number: 1
• Product Code: OES
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: S5078BF09
• Device Catalogue Number: S5078BF09
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/16/2023
• Date Report to Manufacturer: 07/06/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 18615 DA