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

Model Number DYNJ9425843L

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/26/2020

Event Type  malfunction  

Event Description

Dr.Was inspecting the right lung after completing a rml (right middle lobe) and rul (right upper lobe) wedge.Dr found a 1-1.5 cm plastic sheath in the chest.He was able to remove the plastic and the surgical team identified this as a piece of the surgical pencil tip.Dr.Confirmed that all plastic was removed from surgical site.The tip was part of a thoracoscopy pack but is most likely made by a different manufacturer.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; 1 medline place; mundelein IL 60060
• MDR Report Key: 10689814
• MDR Text Key: 211668778
• Report Number: 10689814
• Device Sequence Number: 1
• Product Code: LRO
• 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: 08/28/2020

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 Operator: Health Professional
• Device Model Number: DYNJ9425843L
• Device Catalogue Number: DYNJ9425843L
• Device Lot Number: (10)20EKA540
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/28/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/16/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20075 DA