MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC.; GENERAL SURGERY TRAY

Model Number	DYNDC2409A
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Patient arrived for infusion therapy.When prepping for infusion, the medline port access kit safety shield was already pulled over the needle prior to the package being opened.Costly product not able to be used.Manufacturer response for general surgery tray, medline industries, inc.(per site reporter).Will investigate.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: GENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl; mundelein IL 60060
• MDR Report Key: 13513682
• Report Number: 13513682
• Device Sequence Number: 11813925
• Product Code: LRO
• UDI-Device Identifier: 10889942805693
• UDI-Public: (01)10889942805693(10)2021110390(17)230430
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 02/07/2022
• Report Date (Section F): 02/07/2022

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: DYNDC2409A
• Device Catalogue Number: DYNDC2409A
• Device Lot Number: 2021110390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/11/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/11/2022
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/07/2022