MAUDE Adverse Event Report: CENTURION MEDICAL PRODUCTS CORPORATION CENTURION; CENTRAL VENOUS CATHETER DRESSING CHANGE KIT

Lot Number 2021040890

Device Problems Tear, Rip or Hole in Device Packaging (2385); Defective Device (2588); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem Insufficient Information (4580)

Event Date 06/03/2021

Event Type  malfunction  

Event Description

During inspection of cvad (central venous access devices) dressing kits, end user noted compromised dressing kit with hole in plastic packaging, compromising sterility.Centurion dressing kit: adult cvad / arterial line.Defective packaging sequestered for inspection.

• Brand Name: CENTURION
• Type of Device: CENTRAL VENOUS CATHETER DRESSING CHANGE KIT
• Manufacturer (Section D): CENTURION MEDICAL PRODUCTS CORPORATION; 3310 s main st; salisbury NC 28147
• MDR Report Key: 12083395
• MDR Text Key: 258910190
• Report Number: 12083395
• Device Sequence Number: 1
• Product Code: PEZ
• 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: 06/22/2021

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 Operator: No Information
• Device Lot Number: 2021040890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/22/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/29/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1