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

Model Number	58193
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
While completing a dressing change on a patient a defect with the tegaderm w//chg was discovered on the kit with lot #279271.The rn noticed several cuts around the edges of dressing and after peeling the back paper to apply to patient, the sticky side was faced upward.We look at all dressing in both supply rooms this was the only kit with lot # 279271.Most all others were lot #275593 and these dressings appear to be fine.

• Brand Name: CVC DRESSING KIT TEGADERM
• Common Device Name: CENTRAL VENOUS CATHETER DRESSING CHANGE KIT
• Manufacturer (Section D): MEDICAL ACTION INDUSTRIES INC.; 25 heywood road; arden NC 28704
• MDR Report Key: 11445299
• Report Number: 11445299
• Device Sequence Number: 3618865
• Product Code: PEZ
• UDI-Device Identifier: 10809160008195
• UDI-Public: 0110809160008195
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/09/2021
• Report Date (Section F): 02/09/2021

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: 58193
• Device Catalogue Number: 58193
• Device Lot Number: 279271
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/09/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 02/09/2021