MAUDE Adverse Event Report: MEDICAL ACTION INDUSTRIES INC. KIT: IV 100/CS; I.V. START KIT

Model Number	267014
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The rn (registered nurse) was preparing to start an iv on a patient.When the rn went to open the iv kit packaging, noticed that there was a small, approximately pinpoint mark on the dressing within the kit.The mark on the dressing appears to potentially be a bug stuck to the adhesive on the dressing.

• Brand Name: KIT: IV 100/CS
• Common Device Name: I.V. START KIT
• Manufacturer (Section D): MEDICAL ACTION INDUSTRIES INC.; 1 edison dr.; alpharetta GA 30005
• MDR Report Key: 19142904
• Report Number: 19142904
• Device Sequence Number: 12752587
• Product Code: LRS
• UDI-Device Identifier: 10809160004999
• UDI-Public: (01)10809160004999
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/03/2024
• Report Date (Section F): 04/03/2024

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 Model Number: 267014
• Device Catalogue Number: 267014
• Device Lot Number: 316694
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2024
• 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
• Patient Sex: Unknown
• Date Report Sent to FDA: 04/03/2024