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

Model Number 77433

Device Problem Contamination (1120)

Patient Problem Insufficient Information (4580)

Event Date 08/31/2021

Event Type  malfunction  

Event Description

Opened up a sterile cvc redress kit and a hair was found laying on top of the mask.Obtained a new kit to access port on preop patient.Product and packaging saved.

• Brand Name: MEDICAL ACTION INDUSTRIES
• Type of Device: CENTRAL VENOUS CATHETER DRESSING CHANGE KIT
• Manufacturer (Section D): MEDICAL ACTION INDUSTRIES INC.; 25 heywood road; arden NC 28704
• MDR Report Key: 12480380
• MDR Text Key: 271676076
• Report Number: 12480380
• Device Sequence Number: 1
• Product Code: PEZ
• UDI-Device Identifier: 10809160189887
• UDI-Public: (01)10809160189887(17)221130(10)284974
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/01/2021,08/31/2021

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: Health Professional
• Device Model Number: 77433
• Device Catalogue Number: 77433
• Device Lot Number: 284974
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/01/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1