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

Model Number	77433
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/31/2021
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: CENTRAL VENOUS CATHETER DRESSING CHANGE KIT
• MDR Report Key: 12480380
• Report Number: 12480380
• Device Sequence Number: 14415098
• Product Code: PEZ
• UDI-Device Identifier: 10809160189887
• UDI-Public: (01)10809160189887(17)221130(10)284974
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/31/2021
• Report Date (Section F): 09/01/2021

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
• Operator of Device: 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
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/01/2021