MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC.; I.V. START KIT

Model Number	DYND74285
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medline iv start kit 3m tegaderm from kit does not have window cut.Unable to be used.Additional kit opened.This had had multiple occurrences recently.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: I.V. START KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 17563297
• Report Number: 17563297
• Device Sequence Number: 15169328
• Product Code: LRS
• UDI-Device Identifier: 10884389529188
• UDI-Public: (01)10884389529188
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 05/17/2023
• Report Date (Section F): 05/17/2023

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: DYND74285
• Device Catalogue Number: DYND74285
• Device Lot Number: (10)23CBN120
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/17/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/17/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/17/2023