MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. KIDNEY-PANCREAS PACK; GENERAL SURGERY TRAY

Model Number	DYNJ66312
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
When doctor activated the skin stapler, the staple misfired and did not staple.Staple is pointing out from stapler.Defective stapler collected from sterile field and a new skin stapler presented to sterile field.

• Brand Name: KIDNEY-PANCREAS PACK
• Common Device Name: GENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• MDR Report Key: 15012462
• Report Number: 15012462
• Device Sequence Number: 2368080
• Product Code: LRO
• UDI-Device Identifier: 10193489335729
• UDI-Public: (01)10193489335729
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/07/2022
• Report Date (Section F): 07/07/2022

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: DYNJ66312
• Device Catalogue Number: DYNJ66312
• Device Lot Number: 21JBM505
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 07/14/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/14/2022
• 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: 07/07/2022