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

Model Number DYNJ66312

Device Problems Misfire (2532); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 05/19/2022

Event Type  malfunction  

Event 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
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• MDR Report Key: 15012462
• MDR Text Key: 295864689
• Report Number: 15012462
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10193489335729
• UDI-Public: (01)10193489335729
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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 Sent to FDA: 07/07/2022
• Date Report to Manufacturer: 07/14/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 13505 DA