MAUDE Adverse Event Report: MEDICAL ACTION INDUSTRIES INC. MEDICAL ACTION INDUSTRIES; CENTRAL VENOUS CATHETER DRESSING CHANGE KIT

Model Number 77433

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

Event Date 04/28/2023

Event Type  malfunction  

Event Description

Chloraprep in cvc redress kit was dry.

• Brand Name: MEDICAL ACTION INDUSTRIES
• Type of Device: CENTRAL VENOUS CATHETER DRESSING CHANGE KIT
• Manufacturer (Section D): MEDICAL ACTION INDUSTRIES INC.; 25 heywood rd; arden NC 28704
• MDR Report Key: 17755291
• MDR Text Key: 323498802
• Report Number: 17755291
• Device Sequence Number: 1
• Product Code: PEZ
• UDI-Device Identifier: 10809160189887
• UDI-Public: (01)10809160189887
• 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: 06/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 77433
• Device Catalogue Number: 77433
• Device Lot Number: 306512
• 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: 06/06/2023
• Event Location: Hospital
• Date Report to Manufacturer: 09/15/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1